Quality System Specialist Job at Aptiv plc (Krakow)

Quality System Specialist

Bio-Rad’s Global Quality Management Systems (QMS) team seeks a highly skilled an...

Location

Hungary , Budapest

Salary:

Not provided

Bio-Rad Laboratories

Expiration Date

Until further notice

Requirements

Bachelor’s degree in quality management, business administration, or a similar field
3 or more years’ experience managing an electronic system within a regulated industry, preferably a QMS application for processes such as document management, CAPA, change control or similar
Veeva platform a plus
Experience with system software validation highly desired
Experience within the IVD, medical device or similarly regulated industry highly desired
Excellent attention to detail and problem-solving skills
Ability to comfortably work both independently and collaboratively with internal business/technical team members from around the world
Exceptional communication skills are essential
Ability to travel as needed (infrequent)

Job Responsibility

Support the development, governance and maintenance of the Veeva platform in support of the organization’s Quality Management System in partnership with the IT System Administrator
Support cross-functional partners to manage Veeva applications (current and future)
Manage the incident and change request logs and develop mechanisms for review, approval/rejection, prioritization and communication of implemented changes to stakeholders and system users
Partner with stakeholders and vendors to implement and validate new applications, scheduled updates, and approved changes for movement into production
Provide training and support to end-users to ensure proficient use of the Veeva platform and adherence to established processes
Maintain system documentation, including system technical specifications and test scripts, standard operating procedures, user guides and training materials specific to the Veeva platform
Track and report on system performance, providing insights and recommendations for continuous improvement
Respond to system and process inquiries to support RAQA teams such as for audits and inspections

What we offer

Life and accident insurance
Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
Competitive salary and cafeteria
100% commuting allowance for non-Budapest residents, monthly BKK pass
Annual bonus
Annual salary review
Marriage and childbirth allowance
School start allowance
Loyalty award
Employee Referral Program with remarkable referral bonus

Fulltime

Quality System Specialist

As part of the global post market surveillance reporting team, the new colleague...

Location

Hungary , Budapest

Salary:

Not provided

Bio-Rad Laboratories

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred
5+ years experience in a regulated manufacturing industry or equivalent combination of education and experience
Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad
Understanding of product post market surveillance requirements for IVD products a plus
Working knowledge of device/drug/biotech manufacturing processes
Detail-oriented and ability to multitask
Problem solving, decision making, time management, organization, communication, leadership, and computer skills
Advanced technical writing and word processing skills
Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus
Fluent English, advanced language knowledge skills in reading and writing

Job Responsibility

Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports
Analysis of post market data and reviewing completed reports with business partners
Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance
Maintain, archive and completed controlled quality records
Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners
Facilitate and/or chair local/regional PMS Board meetings
Support various QMS and PMS projects (local and global) as needed
Support internal/external audits as needed
Perform other related duties and assignments as needed

What we offer

Life and accident insurance
Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
Competitive salary and cafeteria
100% commuting allowance for non Budapest residents
Annual bonus
Annual salary review
Marriage and childbirth allowance
School start allowance
Loyalty award
Employee Referral Program with remarkable referral bonus

Fulltime

Quality System Specialist

Bio-Rad’s Global Quality Management Systems (QMS) team seeks a highly skilled an...

Location

Hungary , Budapest

Salary:

Not provided

Bio-Rad Laboratories

Expiration Date

Until further notice

Requirements

Bachelor’s degree in quality management, business administration, or a similar field
3 or more years’ experience managing an electronic system within a regulated industry, preferably a QMS application for processes such as document management, CAPA, change control or similar
Veeva platform a plus
Experience with system software validation highly desired
Experience within the IVD, medical device or similarly regulated industry highly desired
Excellent attention to detail and problem-solving skills
Ability to comfortably work both independently and collaboratively with internal business/technical team members from around the world
Exceptional communication skills are essential
Ability to travel as needed (infrequent)

Job Responsibility

Support the development, governance and maintenance of the Veeva platform in support of the organization’s Quality Management System in partnership with the IT System Administrator
Support cross-functional partners to manage Veeva applications (current and future)
Manage the incident and change request logs and develop mechanisms for review, approval/rejection, prioritization and communication of implemented changes to stakeholders and system users
Partner with stakeholders and vendors to implement and validate new applications, scheduled updates, and approved changes for movement into production
Provide training and support to end-users to ensure proficient use of the Veeva platform and adherence to established processes
Maintain system documentation, including system technical specifications and test scripts, standard operating procedures, user guides and training materials specific to the Veeva platform
Track and report on system performance, providing insights and recommendations for continuous improvement
Respond to system and process inquiries to support RAQA teams such as for audits and inspections

What we offer

Life and accident insurance
Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
Competitive salary and cafeteria
100% commuting allowance for non-Budapest residents, monthly BKK pass
Annual bonus
Annual salary review
Marriage and childbirth allowance
School start allowance
Loyalty award
Employee Referral Program with remarkable referral bonus

Quality System Specialist

As part of the global post market surveillance reporting team, the new colleague...

Location

Hungary , Budapest

Salary:

Not provided

Bio-Rad Laboratories

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred
5+ years experience in a regulated manufacturing industry or equivalent combination of education and experience
Understanding of GMP and quality system standards as they apply to products manufactured by Bio-Rad
Understanding of product post market surveillance requirements for IVD products a plus
Working knowledge of device/drug/biotech manufacturing processes
Detail-oriented and ability to multitask
Problem solving, decision making, time management, organization, communication, leadership, and computer skills
Advanced technical writing and word processing skills
Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise) a plus
Fluent English, advanced language knowledge skills in reading and writing

Job Responsibility

Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports
Analysis of post market data and reviewing completed reports with business partners
Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance
Maintain, archive and completed controlled quality records
Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners
Facilitate and/or chair local/regional PMS Board meetings
Support various QMS and PMS projects (local and global) as needed
Support internal/external audits as needed
Perform other related duties and assignments as needed

What we offer

Life and accident insurance
Private Health Care Services – unlimited examinations, checkups in numerous specialties free of charge
Competitive salary and cafeteria
100% commuting allowance for non Budapest residents
Annual bonus
Annual salary review
Marriage and childbirth allowance
School start allowance
Loyalty award
Employee Referral Program with remarkable referral bonus

Fulltime

Quality System Specialist 2

Under the direction of the Complaints Management, the Quality System Specialist ...

Location

United States , San Antonio

Salary:

28.00 - 30.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum 1+ years of experience with Medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations
Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations
Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker
Knowledge of product failure modes
Ability to work with customer system administrators and clinicians
Proven ability to maintain a professional demeanor when handling complex user issues and high pressure situations
Expert level knowledge of the Complaints handling system
Proven ability to multi-task and seamlessly move between business unit platforms
Ability to take ownership and think independently, with minimal supervision

Job Responsibility

Manage activities and procedures associated with complaints concerning BD products including reviewing customer complaints and potentially filing the Medical Device Reports (MDR’s) associated with complaints to the FDA
Processing of product complaints including but not limited to customer communication (e.g. Email’s, phone calls) and interacting with health care workers, consumers and other professionals regarding their product quality concerns
Maintenance of complaint files and responses to customers
Create final letters and or review for accuracy to ensure that all customers’ requirements have been met
Escalation of quality issues, in order to get resolution and or Business responses for the customer
Manage the process of the complaint handling system including, receipt of complaints from all sources and all in process steps including data entry
Routing the complaint to appropriate location for further evaluation
Entering of the complaint into the complaint handling system
Checking for complaint accuracy and content, correct information to process the complaint
Follow procedures to ensure timely and accurate review of customer complaints and filing of MDRs with the FDA

Fulltime

Quality Management System Specialist

Purpose of the Position: To ensure the establishment, maintenance, development, ...

Location

Romania , Giurgiu

Salary:

Not provided

Randstad

Expiration Date

July 31, 2026

Requirements

Bachelor's degree in Engineering or a related field
Minimum 3 years of experience in quality management systems
Knowledge of ISO 9001 requirements
Preferably experienced in EN ISO 17025
Internal auditor certification is preferred
Strong technical documentation and reporting skills
Good command of English
Proficient in MS Office applications
Good communication and coordination abilities

Job Responsibility

Ensure the implementation and continuity of ISO 9001, EN ISO 17025, and other relevant quality management systems
Prepare, update, and maintain procedures, instructions, forms, and quality documentation
Plan, conduct, and report internal audits
Coordinate external audits, customer audits, and certification processes
Follow up corrective and preventive actions (CAPA) and evaluate their effectiveness
Manage non-conformity records and conduct root cause analyses
Prepare and report quality performance indicators
Organize training activities to improve quality awareness across departments
Support the resolution process for customer complaints and quality issues
Contribute to supplier quality evaluation processes

What we offer

meal vouchers worth 45 lei/day
private medical insurance at Allianz Tiriac
65% fuel reimbursement
Easter and Christmas bonuses

Fulltime

Quality Management System Country Specialist

Ensure the effective implementation, maintenance, and continuous improvement of ...

Location

Spain , Laguna de Duero, Valladolid

Salary:

Not provided

PPG Industries

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Chemistry, or a related technical field
Minimum 2 years of proven experience in a manufacturing environment covering Quality Management Systems (integrated quality systems), internal audits, and the use of data analysis, data collection, and reporting systems to monitor performance and support decision‑making
Ability to manage through difficult and challenging situations, problem solving, and perform root cause analysis
Experience managing corrective and preventive actions and driving continuous improvement initiatives
Strong analytical, organizational, and communication skills
Fluency in English
Availability to travel between the Valladolid and Valencia manufacturing plants

Job Responsibility

Develop and maintain quality standards: Provide guidance and support during the implementation of Quality System in new processes, ensuring they meet applicable requirements (standards + customer)
Maintain the Local Quality Management System ensuring correct procedures to meet standard requirements and respond to all matters of management system certification
Maintain, control, and communicate Quality System documentation
Supervise and conduct internal audits and customer self-assessment
Coordinate / perform system, process, and product internal audits (first party audits) as well as random, KCC and LPA
Perform any kind of internal audit required to meet IATF, PPG and/or CSR
Deploy / perform third party audits according to yearly plan
Lead customer audits
Coordinate any kind of corrective action on audit non-conformances and observations
Deliver a Quality Training Program for any new employee

Fulltime

Quality and Safety System Specialist

At Boeing, we innovate and collaborate to make the world a better place. We're c...

Location

Australia , Brisbane

Salary:

Not provided

Boeing

Expiration Date

Until further notice

Requirements

Tertiary qualifications in engineering, quality, safety, aviation management or a related discipline, or equivalent relevant experience
Demonstrated experience in a Quality, Safety, or related role within aerospace, defence, aviation, manufacturing or another complex, regulated environment
Experience supporting operational, program or business unit delivery environments
Working knowledge of management systems and relevant standards/frameworks, including AS9100/ISO 9001 and applicable SMS regulatory or industry frameworks
Experience in assurance, auditing, risk management, investigation, corrective action management and continuous improvement
Proven ability to build strong working relationships, influence stakeholders and provide practical support in a delivery-focused environment
Strong communication, problem-solving and organisational skills
Lead Auditor qualifications and/or experience in aviation, aerospace or defence environments will be highly regarded
Applicants must be Australian Citizens to meet defence security requirements

Job Responsibility

Support the delivery of Quality and Safety services across the Joint Systems business unit in partnership with program and functional leadership
Provide day-to-day advice and support to business leaders, program teams and employees on Quality and SMS matters
Assist in the implementation, maintenance and continual improvement of the business unit's QMS and SMS
Partner with operational and program teams to help integrate Quality and SMS requirements into planning, execution and performance activities
Support governance activities across the business unit, including compliance obligations, policies, procedures, standards, approvals and management system controls
Participate in assurance activities including internal audits, inspections, reviews and management system health checks, and support readiness for customer, regulatory and certification activities as required
Monitor and report performance data, including quality issues, safety occurrences, risks, audit findings, corrective actions, trends and improvement initiatives
Support the identification, assessment and management of quality and operational safety risks, and assist in the implementation and sustainment of effective controls
Assist with investigations, root cause analysis, corrective and preventive actions, and lessons learned activities
Promote a positive Quality and Safety culture through stakeholder engagement, coaching, communication and support for capability development

What we offer

Flexible working options
Study assistance
Salary packaging
Employee Incentive Program
Global opportunities

Fulltime

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