Calibration & Compliance Specialist Job at Volkswagen AG (Oxnard)

GMP Engineering Compliance Specialist

We are seeking an Engineering Compliance Specialist to support engineering syste...

Location

Singapore , Singapore

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field
Experience in pharmaceutical, biotech, life sciences, or GMP-regulated manufacturing environments
Hands-on or review experience in engineering system checks, asset review, maintenance risk assessments, or calibration activities
Good understanding of GMP documentation practices and engineering compliance requirements
Ability to review engineering records, maintenance records, calibration documentation, and related technical documents
Strong attention to detail, structured working approach, and ability to coordinate effectively with cross-functional stakeholders
Experience in pharmaceutical manufacturing, biologics, sterile manufacturing, or API production is an advantage
Exposure to validation, qualification, CQV, or GMP project support activities is preferred
Familiarity with equipment lifecycle management, preventive maintenance, calibration programs, or asset management systems is an advantage
Experience supporting audit readiness or GMP documentation remediation activities is preferred

Job Responsibility

Support engineering system checks within a GMP manufacturing environment
Review asset records and equipment status to ensure proper documentation and compliance
Conduct or support maintenance risk assessments for manufacturing and engineering systems
Review calibration status, calibration records, and related documentation
Assess whether engineering activities may impact GMP compliance, product quality, or equipment readiness
Collaborate closely with Engineering, Quality, Maintenance, Validation, and Manufacturing teams
Review and support preparation of GMP documentation, reports, checklists, and compliance records
Identify documentation gaps and support follow-up actions or remediation activities
Ensure all work is performed in line with GMP, GDP, and site quality requirements

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact
Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

Fulltime

Senior Chassis Calibration Specialist - Brake Diagnostics

We are seeking an exceptional candidate to join our Active Chassis Calibration t...

Location

Canada , Markham; Oshawa

Salary:

Not provided

General Motors

Expiration Date

Until further notice

Requirements

BS in Mechanical Engineering, Electrical Engineering, or similar
Minimum 5 years of relevant engineering experience (vehicle dynamics, chassis/driveline performance, brake controls, calibration, etc.)
Demonstrated initiative to drive for results in areas of innovation and new development
Thorough physics-based knowledge of vehicle dynamics, brake systems, tire performance
Hands-on experience with vehicle dynamics performance
Experience with measurement equipment, vehicle instrumentation, data acquisition and analysis
Position requires the ability to travel for winter testing in January / February for 2 – 4 weeks
Ability to travel for development and ride trips interspersed throughout the year
Ability to trace/follow C-code to understand controls functions

Job Responsibility

Champion the safety of our employees and customers
Test and analyze data of each brake diagnostic features
Calibrate software packages and features to meet vehicle performance and diagnostic regulation requirements
Take ownership of assigned software features on multiple programs in parallel
Deliver calibrations according to program milestone timing
Work collaboratively with algorithm team to identify and solve issues
Work with performance engineers to seek feedback and ensure vehicle performance meets vehicle and sub-system technical specifications.
Develop common approaches and institutionalize them in Calibration Standard Work (Calibration Procedures, Development Plans, Deliverables, Master Calibration, etc.)
Improve the efficiency and quality of Standard Work by systematically driving present vehicle-based tasks into virtual simulation methods and sub-system hardware benches
Lead technical calibration peer reviews and leadership reviews for assigned program

What we offer

Paid time off including vacation days, holidays, and supplemental benefits for pregnancy, parental and adoption leave.
Healthcare, dental and vision benefits including health care spending account and wellness incentive.
Life insurance plans to cover you and your family.
Company and matching contributions to a Defined Contribution Pension plan to help you save for retirement.
GM Vehicle Purchase Plan for you, your family, and friends.

Fulltime

Post-Market Compliance Specialist III- Autoimmunity

The Post-Market Compliance Specialist III supports product complaint management ...

Location

United States , San Diego

Salary:

80000.00 - 110000.00 USD / Year

werfen

Expiration Date

Until further notice

Requirements

Bachelor’s degree in biological science, biochemistry, or similar field required
Master’s degree preferred
Proficient knowledge of IVD post-market quality system requirements and complaint handling
Advanced knowledge of global IVD post-market regulations and standards
Advanced knowledge with IVD reagents and diagnostic platforms, such as immunoassays, ELISA, chemiluminescent assays, and bead-based multiplex assays on automated systems
Advanced understanding of the functional and performance principles of IVD products, including reagents, calibrators, controls, software, and instrument systems
Minimum of six (6) years of experience in IVD industry in complaint handling, regulatory function, or a closely related technical function, required
Minimum of four (4) years of experience in Autoimmunity IVD, required
Minimum of four (4) years of hands-on laboratory testing of IVD assays including operation of automated IVD instrumentation, execution of test protocols, analysis of test results, and documentation of activities and results, required
Minimum of four (4) years of experience in customer interface responsibilities and complaint handling in an IVD regulated function, required

Job Responsibility

Complaint Management: Intakes, assesses for regulatory reportability, and triages assigned complaints. Designs and executes complex experiments and performs complex complaint investigations including investigation approach determination, experimental design, testing, analyses, and resolution. Triages investigations to other internal departments or manufacturers as needed and follows up with the escalated parties until complaint resolution. Communicates throughout the complaint investigation process from intake to final resolution with customers, affiliates, and internal stakeholders. Presents product issues which should potentially be brought to the Quality Review Board or Field Action Board to PMC management. Prepares presentations and presents issues to QRB and FARB
Laboratory Organization: Maintains laboratory cleanliness and organization. Performs routine cleaning and complete required documentation. Monitors and maintains inventory levels of laboratory test samples, consumables, reagents, and other materials. Ensures laboratory equipment and tools equipment maintenance, calibration, service, and software versions are current
Tracking and Trending: Conducts complaint trend analyses and coordinates the preparation of post-market surveillance (PMS) reports. Prepares Management Review slides on PMS for department management
Field Actions: Authors field action assessments and ensures completion of Health Hazard Evaluations (HHE/HHA) and leads recalls, Field Safety Corrective Actions (FSCAs), Field Safety Notices (FSNs), and associated regulatory notifications
Reportable Events: Completes, files and follow ups on reportable events to regulatory authorities
Department Procedures: Assists in drafting, implementing, and maintaining departmental procedures, work instructions, and templates
Provides technical guidance and mentoring to junior staff. In consultation with department management, develops and executes training for new and developing staff
Complies with applicable standard operating procedures, applicable standards and regula-tions, as well as applicable Environmental Health & Safety, Human Resources and other regulatory and administrative policies
Demonstrates Werfen values through the quality of work and professional working relationships
Other duties as assigned

What we offer

medical, dental, and vision insurance
401k plan retirement benefits with an employer match
paid vacation and sick leave
sales roles are eligible for participation in a commission plan
management and select professional roles are eligible for a performance-based bonus

Specialist Qc Compliance

Role Overview: Specialist QC Compliance The Specialist QC Compliance acts as a S...

Location

Switzerland , Yverdon-les-Bains

Salary:

Not provided

Randstad

Expiration Date

July 31, 2026

Requirements

MSc in Biotechnology, Pharmaceuticals, Engineering, or equivalent industry experience
Minimum 5 years in a GMP environment, with at least 3-5 years specifically in Quality Control
Deep expertise in quality systems (Deviations, CAPA, Change Controls), hands-on equipment software qualification, and strong troubleshooting abilities
Proactive, rigorous, and team-oriented with a proven ability to build trust and work in highly regulated environments
Fluent in both French and English (C1 level or equivalent)

Job Responsibility

Oversee, document, investigate, and close quality events
Ensure the timely execution of deviations, root cause analyses, CAPAs, change controls, and periodic reviews
Coordinate the QC Data Integrity Plan, conduct risk assessments, implement mitigations, and deliver data integrity training to the team
Support the qualification and validation of QC equipment and related software (URS, protocols, risk assessments, reports)
Track equipment work orders, maintenance, and calibration records
Assist with QC sample management (reception, aliquoting, LIMS entry), material release, and monthly reviews of environmental monitoring system (EMS) alarms
Author, review, and maintain SOPs and related quality documents
Participate in audit/inspection readiness and address any observations
Monitor and coordinate the implementation of regulatory and pharmacopoeial updates

Fulltime

Calibration Technical Specialist - Low Voltage Infrastructure

GM's Low Voltage Infrastructure Team within the Embedded Platform Systems & Infr...

Location

United States , Milford

Salary:

Not provided

General Motors

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical, Electrical, Computer, or Chemical Engineering
Minimum 7 years of overall job-related engineering experience
Minimum 5 years of Calibration specific experience
Strong background in calibration/controls, including associated tools (MATLAB, Simulink, INCA, CRETA, Vehicle Spy, CalCheck, JIRA, etc.)
High proficiency in root causing and triaging complex vehicle and system-level issues, with demonstrated ability to lead structured problem-solving efforts, drive issues to closure, and implement corrective actions across hardware, software, and calibration domains
Expertise with 12V/Low Voltage Electric Power Systems and/or Controls (low voltage setpoint control, battery saver modes, and low voltage load management)
Thorough knowledge of calibration process and Calibration Standard Work
Strong leadership skills with demonstrated ability to: Provide technical direction to other engineers and engineering support personnel, Drive global and industry decisions, Lead discussions, action plans, and solutions to drive issues to closure
Exercises independent judgment with minimal input from Engineering Group Manager
Proven leadership capabilities with a track record of driving results, demonstrating initiative, and maintaining strong “it’s on me” ownership

Job Responsibility

Technical leader for Electric Power (12V and Low-Voltage System) calibration for all Electrification and ICE vehicle programs
Lead the development of calibration strategies
serve as the Calibration Strategy Lead and Future Calibration Strategy Lead, developing and evolving Low Voltage Infrastructure calibration approaches to support next-generation Electric Power architectures
Develop common approaches and institutionalize them in Calibration Standard Work (Calibration Procedures, Cal Planner, Deliverables, Master Calibration, Cal Guides, CEGs / Cal Check, etc.)
Serve as the Calibration SME and Technical Leader to all LVI Scrums and TRBs, providing expert-level calibration guidance and ensuring alignment across all active programs
Serve as the Technical Response and Triage Expert and Lead
drive identification, prioritization, and resolution of technical issues through structured triage processes and lead a Calibration TRB
Identify and resolve requirement gaps in partnership with Technical Owners, ensuring calibration requirements are complete, accurate, and aligned across subsystems and programs
Improve the efficiency and quality of Calibration Standard Work by systematically driving present vehicle-based tasks into Lab and/or Math/Virtual environments
Mentor Calibration Engineers, providing technical training and establishing good communication and knowledge-sharing

What we offer

medical
dental
vision
Health Savings Account
Flexible Spending Accounts
retirement savings plan
sickness and accident benefits
life insurance
paid vacation & holidays
tuition assistance programs

Fulltime

Calibration and Metrology Specialist

As a Calibration and Metrology Specialist at Airbus Aerostructures S.R.L., you w...

Location

Romania , Brasov

Salary:

Not provided

Airbus

Expiration Date

Until further notice

Requirements

Bachelor's degree in Metrology, Mechanical Engineering, Electrical Engineering, or a related technical field. Equivalent practical experience combined with relevant certifications will also be considered
Minimum of 3-5 years of experience in calibration and metrology within a manufacturing environment, preferably in aerospace or a highly regulated industry
Strong understanding of metrology principles, including uncertainty analysis, traceability, and measurement system analysis (MSA)
Proficiency in operating and calibrating a variety of precision measurement equipment (e.g., CMMs, vision systems, optical comparators, height gauges, torque wrenches, pressure gauges)
Familiarity with common metrology software and data acquisition systems
Ability to read and interpret technical drawings, blueprints, and GD&T specifications
Experience with quality management systems (e.g., AS9100, ISO 17025)
Excellent analytical and problem-solving skills with a keen eye for detail
Strong verbal and written communication skills, with the ability to effectively collaborate with cross-functional teams

Job Responsibility

Define calibration requirements for various metrology equipment, including but not limited to CMMs, optical measurement systems, gauges, micrometers, and other precision instruments, following established procedures and industry standards
Develop, review, and update calibration procedures, work instructions, and documentation to ensure compliance with internal quality management systems (e.g., AS9100) and external regulatory requirements
Analyze calibration data, identify trends, and recommend corrective actions to maintain instrument accuracy and optimize calibration intervals
Conduct measurement system analysis (MSA) studies, including Gauge R&R, linearity, and bias, to assess the suitability of measurement systems
Support root cause analysis and problem-solving activities related to measurement discrepancies and equipment failures
Collaborate with engineering, production, and quality teams to understand measurement needs and provide metrology expertise
Manage and maintain the calibration database, ensuring accurate and up-to-date records of all calibrated equipment
Assist in the selection, procurement, and qualification of new measurement equipment
Provide training and technical support to other team members on metrology principles and equipment operation
Ensure adherence to all safety protocols and company policies

Fulltime

Regional Sales Manager, Interventional Pain - North Central

Here at Avanos Medical, we passionately believe in three things: Making a differ...

Location

United States

Salary:

100000.00 - 140000.00 USD / Year

Avanos

Expiration Date

Until further notice

Requirements

Bachelor's Degree Required
At least five years of demonstrated success in medical device sales
At least 2 or more years’ experience in Medical Device Sales Management, with a proven record of accomplishment
Strong leadership qualities
Proficient with MS Office Suite applications
Extensive in-field travel required
Must be able to lift 35 pounds

Job Responsibility

Coach and Develop team members to execute the established revenue goals within the framework of the corporate strategy
Provide Coaching and Development to assess the strengths & weaknesses of each employee and establish a plan for continuous improvement
Ensure that each employee has awareness of and access to the appropriate resources to continuously improve through the documented
Develop, monitor and adjust (as needed) robust Territory Business Plans with members of the regional sales team
Proactively communicate with the regional sales team on a weekly basis, including regular conference calls to assess sales leads and performance (and adjust as necessary)
Conduct field ride-along visits to include 2 days per week with Territory Manager/Sales Representative and 1 day per week with Sales Associate and Clinical Specialists (where applicable)
file Field Follow Up Reports for each visit
Fully understand and leverage tools, reports and analyses provided by analytics team
Communicate promptly and clearly any misunderstanding around reporting and analyses
Leverage salesforce.com to help regional sales team to effectively manage sales cycle and harvesting leads

What we offer

generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
benefits on day 1
free onsite gym
onsite cafeteria
uncapped sales commissions

Fulltime

Multi Skilled Engineer

As a Multi Skilled Maintenance Engineer, you will play a vital role in ensuring ...

Location

United Kingdom , Deeside

Salary:

Not provided

Morrisons

Expiration Date

June 19, 2026

Requirements

Qualifications to NVQ level 3 (or equivalent, ONC mechanical/electrical engineering, BTEC level 3 in mechanical & electrical/electronic engineering)
Strong knowledge of mechanical and electrical systems used in FMCG industry
Proficient in troubleshooting and repairing industrial machinery, including conveyors, motors, pumps, and packaging equipment
Proactive approach to maintenance and a commitment to ensuring the highest levels of equipment reliability
A good understanding of HACCP principles and ideally IEE qualification up to 17th edition wiring regulations would be advantageous
Excellent communication skills
Assertiveness with the ability to make decisions on the spot
A can do attitude and a strong work ethic

Job Responsibility

Conduct routine inspections and preventive maintenance on production equipment, identifying and resolving any potential issues before they cause disruptions
Respond promptly to machinery breakdowns, diagnose the problem, and perform repairs or coordinate with external specialists when necessary
Carry out machine adjustments and changeovers to support production line efficiency and minimise downtime
Monitor and calibrate equipment to ensure accuracy, quality, and safety standards are met
Collaborate with production teams to identify opportunities for process improvement and provide technical expertise to enhance productivity
Keep accurate records of maintenance activities, including maintenance schedules, repairs, and spare parts inventory
Adhere to health and safety guidelines and ensure compliance with company policies and procedures
Stay updated with industry advancements and new technologies relevant to the role

What we offer

Six weeks holiday (including bank holidays)
15% discount in our stores available from the day you join us
Additional 10% discount card for a friend or family member
Career progression and development opportunities
Subsidised staff canteen
Free parking
Market leading pension and life assurance
Healthcare/Well-being benefits including Aviva Digital GP
Morrisons MyPerks with discounts at high street shops, cinemas and gyms, and lots more
Long Service Awards

Fulltime

Select Country

Calibration & Compliance Specialist

Job Description

Job Responsibility

Requirements

Nice to have

Looking for more opportunities?