Quality & Regulatory Engineer II Job at Randstad (Basingstoke)

Quality Engineer II

We are seeking a detail-oriented and proactive Quality Engineer with experience ...

Location

United States , Longmont

Salary:

73000.00 - 90000.00 USD / Year

Antech Diagnostics

Expiration Date

Until further notice

Requirements

Bachelor's degree in biotechnology, Biomedical Engineering, Biology, or related field
A minimum of 4-7+ years of quality assurance experience, preferably in a regulated industry or equivalent combination of education and experience
Familiarity with GMP, GLP, QSR, and ISO 9001/13485 standards
Experience managing nonconforming materials, investigations, and dispositions
Proficiency in quality tools such as CAPA, FMEA, Root Cause Analysis, and 8D
Solid documentation, analytical, and communication skills

Job Responsibility

Provide quality engineering support to manufacturing operations, including batch record review, deviation management, and in-process control monitoring
Assist in resolving quality issues on the production floor by collaborating with manufacturing, quality control, and engineering teams
Implement, and maintain quality systems in compliance with standard requirements and regulations (e.g., USDA APHIS, FDA CVM, ISO)
Support validation and qualification of manufacturing equipment, utilities, and processes (IQ/OQ/PQ)
Manage Nonconforming Material Reports (NCMRs), including investigation, segregation, documentation, and disposition of nonconforming products, and leading the Material Review Board
Lead and participate in root cause investigations and implement corrective and preventive actions (CAPA) related to manufacturing deviations and product issues
Collaborate with Operations, R&D and regulatory teams during the development and scale-up of new products
Analyze trends in manufacturing quality data to identify opportunities for continuous improvement and risk reduction
Support lot release testing, stability studies, and regulatory compliance activities
Conduct and support internal and external audits, including USDA CVB and FDA CVM inspections

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

Fulltime

Quality Engineer II

We are seeking a detail-oriented and proactive Quality Engineer with experience ...

Location

United States , Rockville

Salary:

70000.00 - 90000.00 USD / Year

Antech Diagnostics

Expiration Date

Until further notice

Requirements

Bachelor's degree in biotechnology, Biomedical Engineering, Biology, or related field
A minimum of 4-7+ years of quality assurance experience, preferably in a regulated industry or equivalent combination of education and experience
Familiarity with GMP, GLP, QSR, and ISO 9001/13485 standards
Experience managing nonconforming materials, investigations, and dispositions
Proficiency in quality tools such as CAPA, FMEA, Root Cause Analysis, and 8D
Solid documentation, analytical, and communication skills
Experience supporting biologics manufacturing in a USDA-licensed facility
Knowledge of aseptic manufacturing and cleanroom compliance requirements
Certified Quality Engineer (CQE) or Six Sigma certification
Experience supporting regulatory inspections (USDA CVB, FDA CVM)

Job Responsibility

Provide quality engineering support to manufacturing operations, including batch record review, deviation management, and in-process control monitoring
Assist in resolving quality issues on the production floor by collaborating with manufacturing, quality control, and engineering teams
Implement, and maintain quality systems in compliance with standard requirements and regulations (e.g., USDA APHIS, FDA CVM, ISO)
Support validation and qualification of manufacturing equipment, utilities, and processes (IQ/OQ/PQ)
Manage Nonconforming Material Reports (NCMRs), including investigation, segregation, documentation, and disposition of nonconforming products, and leading the Material Review Board
Lead and participate in root cause investigations and implement corrective and preventive actions (CAPA) related to manufacturing deviations and product issues
Collaborate with Operations, R&D and regulatory teams during the development and scale-up of new products
Analyze trends in manufacturing quality data to identify opportunities for continuous improvement and risk reduction
Support lot release testing, stability studies, and regulatory compliance activities
Conduct and support internal and external audits, including USDA CVB and FDA CVM inspections

What we offer

Paid Time Off & Holidays
Medical, Dental, Vision (Multiple Plans Available)
Basic Life (Company Paid) & Supplemental Life
Short and Long Term Disability (Company Paid)
Flexible Spending Accounts/Health Savings Accounts
Paid Parental Leave
401(k) with company match
Tuition/Continuing Education Reimbursement
Life Assistance Program
Pet Care Discounts

Fulltime

Quality Engineer II

The Quality Engineer II is responsible for supporting Design Quality Assurance w...

Location

United States , Vernon Hills

Salary:

34.00 - 38.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum 3 years design controls and risk management experience with medical devices
Pharmaceutical knowledge of combination products, preferred
Strong knowledge of regulatory requirements (21CFR§4, 21CFR§210&211, 21CFR§820, ISO 13485, CMDR, MDD/EU MDR, and J-PAL)
Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.)
Attentiveness to details with strong organizational and time management skills
Excellent verbal and written communication skills and interpersonal skills
Ability to work in a team environment
Proficiency in Excel, Word, PowerPoint and other desktop/general business systems
Position requires a Bachelor of Science degree in Chemistry or Engineering from an accredited four (4) year university

Job Responsibility

Supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering
Works cross-functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects and change to win (CTW) projects
Work under general direction to exercise judgment within generally defined policies and procedures to select methods and techniques to obtain solutions to problems with broad scope and complexity
Work closely with business unit and manufacturing plant management as well as other functions (e.g., Regulatory Affairs, Research and Development, Sustaining Engineering, Manufacturing Quality, Operations, Sterility Assurance, Packaging, Sales, Marketing, Finance etc.)
Works cross-functionally with business unit management, as well as their respective teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects and plans

Fulltime

Engineer II / Scientist II

Primary focus of this position is to support in developing, optimizing, implemen...

Location

United States , Tempe

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

Bachelors degree in Engineering or Science plus 1 year of experience

Job Responsibility

Design components of a medical device, translating intangible design inputs into tangible engineering specifications and drawings
Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards
Build test parts for engineering evaluation, pre-clinical studies and clinical studies
assists in the development and optimization of processes to understand key process inputs and outputs, using statistic methods such as DOE as appropriate
Supports new process equipment and tooling development, including specification development, vendor selection and negotiation
prepare work instructions and standard operating procedures (SOP), write technical documents and reports
Prepare raw material specifications and drawings
Assist in preparing verification and validation protocols and reports
develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians
prepare and assist in the validation of test methods

New

Electrical Engineer II

Merrick & Company is seeking an experienced Laboratory / Facility Electrical Eng...

Location

Canada , Kanata

Salary:

80000.00 - 104000.00 CAD / Year

Merrick & Company

Expiration Date

July 03, 2026

Requirements

Four (4) to eight (8) years of experience in Electrical Engineering design
Professional Engineer (P.Eng) license in Electrical Engineering is highly desired, or the ability to obtain P.Eng licensure within 2 years of hire
Accredited Electrical Engineering Bachelor’s degree
At least four (4) years of experience using Revit, AutoCAD, or similar design software for drawing production
Experience with electrical calculation tools is preferred, including lighting and power software such as AGi32, ElumTools, SKM Power Tools, ETAP, or EasyPower
Proficiency in Microsoft Excel and Word
Strong knowledge of applicable technical codes and standards, including CEC, NBC, CAN/ULC-S534 and IEEE
Client requirements for this position require Canadian citizenship or permanent resident status qualified with minimum Reliability clearance level.

Job Responsibility

Design electrical systems for laboratory and facility projects for government, university, and private-sector clients
Develop conceptual and detailed designs for facility power distribution, site power distribution, emergency power generation, grounding and lightning protection, lighting, telecommunications, fire alarm / mass notification, security, access control, and other special systems
Prepare supporting calculations, technical reports, and project specifications
Apply and interpret applicable electrical codes and regulatory requirements
Meet with clients to define, validate, and refine project scope
Support the preparation of engineering fee proposals
Coordinate closely with other disciplines to deliver accurate, high-quality work that meets schedule and budget requirements
Manage priorities effectively and deliver work on time
Travel as needed to support projects and client needs
Write, review, and edit technical specifications

What we offer

Comprehensive Compensation & Benefits – Merrick & Company offers a competitive compensation and benefits package including health insurance, dental and vision coverage, and paid time off (PTO)
Robust Referral Program – Earn incentives for referring top talent to join our team
Performance Reviews – Annual reviews to recognize contributions and support career growth
Professional Development – Access to ongoing training and development opportunities to build your skills and advance your career
Employee Recognition – Formal programs to celebrate achievements and outstanding performance
Peer Mentor Program – Get support and guidance through structured mentorship opportunities
And More – Additional programs and benefits designed to support your success and well-being.

Fulltime

New

Q&RA Engineer II

Quality & Regulatory Affairs (Q&RA) Engineer II Location: Basingstoke (Remote wi...

Location

United Kingdom , Basingstoke

Salary:

27.00 GBP / Hour

Randstad

Expiration Date

July 02, 2026

Requirements

Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of experience in QA/QC OR an Advanced degree with 3+ years of relevant experience
Proven background working in highly regulated industries (Pharmaceutical, Medical Device, or Biotech preferred)
Comprehensive experience with Enterprise Quality Management Systems (EQMS), Document Control Systems, CAPA processes, deviation management, and change control
Demonstrated expertise in advanced root cause analysis, investigation techniques, and corrective action implementation
Experience actively conducting and hosting internal/external audits and regulatory inspections
Strong proficiency in statistical analysis, data trending, and quality metrics reporting
Project management experience is highly preferred
Deep knowledge of GMP/GxP regulations, ISO standards (such as 9001 and 13485), and other relevant quality system requirements
Strong grasp of risk assessment methodologies and continuous improvement tools
Advanced technical writing skills for authoring precise SOPs and investigation reports

Job Responsibility

Compliance & Audits: Support and maintain robust compliance with GMP/GxP, ISO, and global regulatory requirements. Conduct and support both internal and external audits and regulatory inspections
Investigations & CAPA: Investigate complex quality issues, lead root-cause analysis efforts, and collaborate across departments to drive effective corrective and preventive actions (CAPA)
Documentation & Change Control: Author, review, and approve critical quality documentation (including SOPs and investigation reports) and manage change control activities
Data & Metrics: Perform advanced data analysis, trending, and reporting of quality metrics to support system enhancements and continuous improvement initiatives

Fulltime

New

Substation Electrical Engineer II

Bowman has an opportunity for a Substation Electrical Engineer II, Substation to...

Location

United States

Salary:

85000.00 - 115000.00 USD / Year

Bowman

Expiration Date

Until further notice

Requirements

Bachelor's degree in electrical Engineering, Engineering Technology, or related field
equivalent experience may be considered
Engineer‑in‑Training (EIT) preferred
progression toward Professional Engineer (PE) licensure encouraged
Three or more (3+) of progressive CAD/drafting experience, with significant substation or utility experience
Expert proficiency in AutoCAD, MicroStation, or equivalent CAD platforms
Working knowledge of substation equipment, layouts, grounding, and construction methods
Experience with utility drafting standards and document control systems
Proficiency in Microsoft Office applications

Job Responsibility

Provides engineering support, and technical expertise for substation engineering projects
This role independently produces, modifies, and reviews complex substation drawings, ensures compliance with company standards, and serves as a technical resource to support the safe and reliable delivery of substation infrastructures
Serve as a technical resource for substation design, CAD standards, tools, and best practices
Collaborate closely with substation engineers and project managers to translate engineering concepts into accurate, constructible drawings
Support continuous improvement of drafting methods, templates, and workflows
Produce and maintain detailed substation drawings for new construction, expansions, and retrofit projects
Ensure drawing packages comply with company drafting standards, engineering requirements, and regulatory guidelines
Coordinate drawing deliverables with engineering, protection & control, civil/structural, and construction teams
Support project schedules by managing multiple deliverables and prioritizing work effectively
Participate in design reviews and incorporate comments accurately and efficiently

What we offer

Medical, dental, vision, life, and disability insurance
401(k) retirement savings plan with company match
Paid time off, sick leave, and paid holidays
Tuition reimbursement and professional development support
Discretionary bonuses and other performance-based incentives
Employee Assistance Program (EAP), wellness initiatives, and employee discounts

Fulltime

Engineer Ii, Mfg

You as Engineer II, Mfg will develop, optimize, validate, and sustain molding, a...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

A degree in Engineering, or equivalent experience, preferably in one of the following fields: Mechanical Engineering
Mechatronics Engineering
Electrical Engineering
Electronic Engineering
Maintenance Engineering
2-5 years of experience in similar roles within a manufacturing environment
English language proficiency at intermediate level (B2 desirable)

Job Responsibility

Develop, implement and be responsible for the continuous improvement of molding, extrusion and automation processes, through the integration and optimization of robotics, vision systems, PLCs, equipment, tools, resins and electromechanical systems, providing technical support and applying analysis and solving methodologies, in order to minimize downtime, improve reliability and ensure compliance with safety objectives, quality, delivery and cost, as well as the stability, repeatability and capacity of the processes
Promote Lean Manufacturing and Operational Excellence (Opex) initiatives, such as Kaizen, standardized work, Kanban systems, mini-cells and production leveling (Heijunka), to improve flow and efficiency
Be responsible for the development and optimization of manufacturing processes, by identifying, analyzing, and solving problems in processes, equipment, materials, and automation systems, applying principles of scientific molding, Build of Experiments (BOE), Statistical Process Control (SPC), and structured problem-solving methodologies, so as to guarantee operational stability, improve production performance, and maintain alignment with quality objectives, efficiency and productivity
Drive yield improvement and reduce material usage variability (MUV) by analyzing data
Identify and eliminate waste and rework
Reduce downtime and apply continuous improvement and process control techniques
This will optimize Overall Equipment Efficiency (OEE) and improve operational effectiveness and process profitability
Own the specification, acquisition, installation and commissioning of automation systems for molding processes, through the definition of technical requirements, coordination with suppliers, the integration of robotics, vision systems, conveyors and digital interfaces (MES), and the validation of performance in operation, in order to ensure robust, efficient solutions aligned with production needs
Diagnose and resolve faults in automation systems, including hardware, control systems, PLC logic, and electromechanical systems, through technical analysis, test execution, and the application of structured troubleshooting methodologies, in order to minimize downtime and improve operational reliability
Implement automation enhancements to respond to capacity expansion and obsolescence needs, as well as plan and complete IQ/OQ/PQ validation activities for new or modified molding equipment and processes, in compliance with GMP, FDA, ISO 13485, and internal quality systems

Fulltime

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