Quality Systems Manager Job at Bakkavor (Nantwich)

Quality Systems Manager

Location

United States , Burnsville

Salary:

130000.00 - 165000.00 USD / Year

Imricor Medical Systems

Expiration Date

Until further notice

Requirements

Bachelor of Science in a scientific discipline or equivalent education/training
10+ years’ experience in Quality Systems
4+ years within the medical device industry
Comprehensive working knowledge of EU MDR, ISO 13485, 21 CFR 820
Experience leading audits, CAPA systems, and regulatory inspections
Proven ability to effectively influence cross-functional teams

Job Responsibility

Owns, maintains, and improves the Quality Management System in compliance with 21 CFR Part 820, EU MDR, ISO 13485, and other applicable international regulations and guidelines
Ensures effective implementation and ongoing compliance with QMS processes, procedures, and records
Owns and maintains electronic QMS system
Manages document control, record retention, and change control processes
Drives harmonization and simplification of quality documentation where possible
Owns and maintains external document and standards database and drive updates, as applicable
Plans, conducts, and manages internal audits and support external regulatory and customer audits
Acts as the primary interface with regulatory authorities and notified bodies during inspections
Leads audit responses, root cause analysis, and corrective actions to closure
Oversees the Corrective and Preventive Action (CAPA) system, ensuring timely, effective investigations and actions

What we offer

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Fulltime

Quality Systems Manager

Are you looking for a quality leadership role that has a diverse and growing por...

Location

United States , Fort Wayne, IN or Endicott, NY

Salary:

122400.00 - 208080.00 USD / Year

Baesystems

Expiration Date

Until further notice

Requirements

Bachelor's Degree and 8-10+ years of experience or 12-14+ years of relevent experience in lieu of degree
Strong knowledge and experience for obtaining and/or maintaining AS9100 certification is strongly preferred
Experience in the use of root cause analysis (RCCA) tools. Investigating and resolving customer complaints
Strong and Demonstrated Communication Skills (written, verbal, visual) and interpersonal skills (listening and communicating within a group/team/geographically diverse environment)
Exhibits a high degree of technical credibility and communicates highly-technical information in a simplistic and easily understandable way
Ability to work independently

Job Responsibility

Leading the site Business Management System (BMS) and Quality Management System (QMS) implementation and maintenance
Establishing a compliant QMS that meets or exceeds customer requirements and industry standards
Quality Management System design, policy definition, implementation, monitoring and analysis
Planning, developing, reviewing and communicating customer and program quality requirements and expectations
Leading an active engagement with 3rd party AS9100D certification registrar and auditors for planning and executing certification audits
Assessing and determining an implementation plan for IATF 16949 and AS13100
Supporting the site internal audit programs
Driving prevention activities and Opportunities for Improvement across business sites
Supporting Risk Assessments, Lessons Learned and benchmarking
Leading quality training programs

What we offer

health, dental, and vision insurance
health savings accounts
a 401(k) savings plan
disability coverage
life and accident insurance
employee assistance program
legal plan
discounts on things like home, auto, and pet insurance
paid time off
paid holidays

Fulltime

Plant Quality Systems Manager

Reporting to the Manager Quality, the Manager Quality Systems will be responsibl...

Location

United States , Fort Gibson

Salary:

Not provided

Refresco

Expiration Date

Until further notice

Requirements

Proficient in Excel, Word, SAP and Power Point
Ability to analyze and solve problems, results oriented
Organized and detail-oriented, adaptable to change
Able to read and understand metric system
A bachelor’s degree in quality management or a related technical discipline is strongly preferred
A minimum of 5 years of progressive experience in Quality Assurance or Quality Control within a fast-paced manufacturing environment, preferably in the food or beverage industry
Demonstrated experience in the successful implementation, management, and continuous improvement of Quality System Software
In-depth understanding of Global Food Safety Initiative (GFSI) standards, such as Safe Quality Food (SQF) or FSSC 22000, with hands-on experience managing compliance and audits
Proven experience working with real-time data collection systems to monitor and analyze production processes

Job Responsibility

Adhere to and ensure compliance to all health and safety policies/procedures, Good Manufacturing Practices (GMPs) and adhere to the required personal protective equipment (PPE)
Adhere to and ensure compliance to food quality and food safety guidelines per Refresco, Customer and/or governing bodies (ex. SQF) standards
Responsible for complying with FDA, state/city regulations, Refresco quality policies, GMP's, HACCP, Allergen, Kosher, etc as well as other regulations required
Provides guidance and training on work standards and expected outcomes
Overall plant owner for quality systems which includes document control and quality data collection applications
Responsible for supporting and maintaining compliance with third-party food safety and quality certification requirements, including the implementation and continual improvement of the facility’s food safety and quality management systems
Responsible for the development, implementation, maintenance, and continuous improvement of the SQF System and ensuring compliance with all relevant food safety and quality requirements
Overall plant owner for audit systems which includes internal audits and external audits
Will audit and verify with the local team to ensure quality systems comply per Refresco corporate guidelines
Plant owner for quality project to ensure proper documentation has been completed such as validation and verification protocols

What we offer

Medical/Dental/Vision Insurance
Health Savings Accounts and Flexible Spending Accounts
Life and AD&D Insurance, critical illness, hospital indemnity, and accident insurance
Short-term disability and long-term disability
Pet Insurance
Legal Benefits
401(k) Savings Plan with Company Match
12 Paid Holidays
Vacation Days and Paid Sick Time Off Days
Well-being Benefit

Fulltime

Senior QA Manager, Quality Systems

We are looking for a Senior QA Manager, Quality Systems to fulfill a temporary p...

Location

Denmark , Søborg

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master's degree in a relevant field and 5+ years of QA experience, preferably within pharmaceutical development
Solid understanding of pharmaceutical quality systems and quality process governance
Demonstrated ability to analyze quality data and deliver clear reporting (e.g., KPIs, dashboards, trend analyses) to support decision-making
Highly organized with the ability to translate structure into effective, sustainable process improvements
Strong communicator and collaborative team player, with a pragmatic and compliant approach
Experience working with electronic QMS/EDMS and reporting tools (e.g., Veeva Vault, Excel, BI) is an advantage

Job Responsibility

Drive and continuously improve the QMR process, including governance, data inputs, facilitation, documentation, follow-up, and effectiveness tracking
Drive continued implementation of the process landscape, ensuring processes are well-defined, understood, and embedded with clear ownership and interfaces
Own and enhance core QA processes (e.g., Change Control, Deviation management, P)) and implement continuous improvements
Build and maintain quality reporting for QMR (e.g., KPIs, dashboards, and trend analyses) using Veeva Vault, Excel, and BI tools to enable timely, decision-ready oversight
Present and represent QA processes, QMR outcomes, and key metrics during audits and inspections, ensuring transparent and consistent communication
Collaborate with IT and key stakeholders to define and communicate requirements for our electronic QMS (Veeva Vault Quality) to support process execution and reporting

Fulltime

Manager, Quality Systems (QMS)

As the Manager, Quality Systems, you will support the design, implementation, an...

Location

Canada , Vancouver

Salary:

94880.00 - 118600.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

Requirements

5+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance
Bachelor’s degree in a relevant scientific or engineering discipline with 8+ years of industry experience in biotechnology, pharmaceuticals, or life sciences
Strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments
Solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions
Experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control
Proactive in identifying opportunities for improvement, with strong critical thinking and problem-solving skills

Job Responsibility

Establishing, supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements
Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements
Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance
Serving as the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle
Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects
Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions
Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments
Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)
Managing QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure
Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

What we offer

Equity
Annual bonus dependent on team and company performance
6% (non-match) RRSP contribution
CAD $1,500 annual Active Lifestyle Allowance
Annual vacation
Professional development opportunities
Comprehensive health benefits
Scientific and technical mentorship
Teams and social groups to build community and connections

Fulltime

New

Manager - Warehouse Quality Systems

In this vital role, you will be part of the Supply Chain team and report to the ...

Location

United States , New Albany

Salary:

105010.70 - 142073.30 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 2 years of Supply Chain experience
OR Bachelor’s degree and 4 years of Supply Chain experience
OR Associate’s degree and 8 years of Supply Chain experience
OR High school diploma / GED and 10 years of Supply Chain experience

Job Responsibility

Ensure compliance with GMP/GDP and EHSS requirements
Own and/or provide input and support for quality systems records (deviations, change control records, CAPA, CAPA EV, SOP, etc.) or other records
Acts as Risk Assessment Facilitator or owner
Assess impact of new requirements, changes, processes, and distribution regulations to the department
Own and lead change controls for the warehouse
Own deviation records for the Warehouse
Participate in revision of controlled documents
Act as warehouse representative in cross departmental projects
Act as a point of contact for other departments (e.g. Packaging, QA, Planning, etc.)
Track performance on specific KPIs- Participate in network meetings

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Quality Systems Architect Manager

GM’s Global Manufacturing Engineering team is advancing the vision of Zero Crash...

Location

United States , Warren

Salary:

Not provided

General Motors

Expiration Date

Until further notice

Requirements

7+ years in manufacturing, quality, metrology, or IT/OT (preferably ME Body / BIW)
2+ years of team leadership experience
Hands-on experience with metrology tools (e.g., PolyWorks, GOM, Keyence, Dataloop) and hardware (CMM, scanners, robotics)
Experience integrating shop-floor systems with MES, PLCs, and enterprise data platforms
Proven ability to design distributed systems (APIs, data pipelines, event streaming)
Strong understanding of Factory 4.0, IT/OT convergence, and industrial cybersecurity
Demonstrated ability to lead cross-functional initiatives and influence at senior levels
Strong communication, problem-solving, and program leadership skills
Bachelor’s in Engineering, Computer Science, or related field

Job Responsibility

Define and govern end-to-end architecture for quality and metrology systems (in-line/off-line measurement, virtual assembly, analytics, visualization)
Integrate metrology assets (CMM, scanners, robotic cells) with plant automation and enterprise data platforms
Ensure solutions meet requirements for safety, cybersecurity, performance, and reliability across edge, on-prem, and cloud environments
Lead adoption of advanced metrology, automation, analytics, and AI/ML to improve quality, launch performance, and cost
Drive pilots/PoCs and transition successful solutions to scalable, production-ready platforms
Serve as primary technical lead across ME, IT, Operations, and Engineering stakeholders
Lead architecture reviews, drive alignment, and translate complex concepts into clear business impact
Establish standards for integration, data models, traceability, and system performance
Enable reusable platforms (APIs, services, toolkits) to reduce custom solutions and accelerate deployment
Drive commonization across Body Manufacturing Engineering and global centers

What we offer

Relocation benefits may be eligible

Fulltime

Quality Systems & Laboratory Manager

As Quality Systems and Laboratory Manager, you’ll take full ownership of the sit...

Location

United Kingdom , Warrington

Salary:

35000.00 - 40000.00 GBP / Year

Quintessential Brands Group

Expiration Date

Until further notice

Requirements

Strong working knowledge of QMS, BRCGS, ISO standards, HACCP, TACCP and VACCP
Experience leading internal audits and managing accreditation standards
Expertise in document control systems and data analysis
Experience managing quality incidents, complaints, NCRs and CAPA processes
The ability to coach and develop teams while maintaining accountability
Confidence liaising with auditors, customers, suppliers and senior management
A proactive mindset focused on prevention, continuous improvement, and operational excellence

Job Responsibility

Own and manage the site QMS and document control systems in line with BRCGS and customer standards
Lead HACCP, TACCP and VACCP programmes, chairing the HACCP team
Act as site lead for external audits, retailers, and certification bodies, ensuring full audit readiness at all times
Manage the internal audit programme and drive corrective actions to closure
Oversee traceability exercises and mock recalls
Develop and maintain all technical documentation required for compliance
Lead and manage the Quality Laboratory, resources, and equipment
Ensure calibration and verification of laboratory and critical production instruments
Manage QA budget for laboratory consumables and raise POs as required
Act as site lead, ensuring accreditation standards are maintained

What we offer

Company pension scheme
Life assurance
Company bonus scheme
25 days holiday
Discounts with high street and online retailers
Staff shop

Fulltime

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Quality Systems Manager

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