Quality Manager Medical Device jobs
Quality Assurance & Regulatory Affairs (QARA) Manager
Urgently neededNewCambrionixCambridge- Travel to contract manufacturers to audit production compliance, resolve quality issues, and align on testing processes.
- Pay: £55,000.00-£60,000.00 per year.
- Dragon RoboticsPembroke Dock SA72 6UN
- Private dental insurance
- Company pension
- Private medical insurance
- Proven experience in a quality management role within medical devices or life sciences, with direct responsibility for an ISO 13485 QMS.
- Bodywise (UK) LtdBristol BS32 4EU
- Annual leave
- Free parking
- Company pension
- Paid volunteer time
- Enhanced maternity leave
- Cycle to work scheme
- Minimum 5 years’ experience working in Quality Assurance and Regulatory Affairs, ISO 13485 within Class II and Class I medical devices.
- Bodywise (UK) LtdBristol BS32 4EU
- Annual leave
- Free parking
- Company pension
- Paid volunteer time
- Enhanced maternity leave
- Cycle to work scheme
- Minimum 5 years’ experience working in Quality Assurance and Regulatory Affairs, ISO 13485 within Class II and Class I medical devices.
- LiaiseLondon N5 1XA
- Annual leave
- Employee discount
- Employee assistance programme
- Company pension
- 3 years experience in quality and compliance role.
- Audit clinical / care practice in accordance with the Internal Quality Assurance Framework and in response to…
- Rubicon People PartnershipDundee
- Act as primary point of contact for customers on quality matters, including escalations and corrective actions.
- Sphere SolutionsTredegar Park ED NP10 8BE
- Support quality reporting and client-facing quality meetings.
- Experience managing quality documentation and inspection records.
Quality Engineer, Quality Department
Urgently neededCONTAMAC LTDSaffron Walden CB11 3AU- Referral programme
- Life insurance
- Free parking
- Company pension
- Company events
- Car scheme
Often responds in 1 day2 hires made in past 30 days- Work collaboratively across the organisation to improve product and process quality, supporting other QA projects and investigations as required.
- CornerstoneHealthcareWaterlooville PO7 7YH
- Paid training
- Referral programme
- Employee assistance programme
- Company pension
- Company events
- Cycle to work scheme
- Demonstrable experience translating quality data into actionable improvement plans.
- Proven experience of designing and implementing quality assurance frameworks…
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Senior Quality Engineer
Urgently neededSterisBishop's StortfordOften responds in 4 days8 hires made in past 30 days- Represent the quality team on projects to ensure compliance with QMS’s.
- To provide Quality support of new product development.
- Able to manage a busy workload.
- Dellner Polymer Solutions LtdBurton-On-Trent
- Referral programme
- Life insurance
- Free parking
- Cycle to work scheme
- Health & wellbeing programme
- Uphold quality assurance certifications and housekeeping standards.
- Lead internal quality investigations using recognised tools (5 Why, Ishikawa, 8D).
- Allegis Global Solutions RPO UK for GSKLondon WC1A 1DG
- Experience maintaining a Pharmacovigilance quality assurance programme.
- Experience developing and maintaining networks across quality and compliance groups and…
- PharmaxoCorsham
- Company pension
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- Every day, our teams prepare lifesaving medicines with exceptional accuracy and quality, ensuring patients across the NHS and partner hospitals receive their…
- CSLLiverpool L24 9JW
- The role holder ensures that quality systems consistently.
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- LonzaSlough SL1 4DX
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Job Post Details
Quality Assurance & Regulatory Affairs (QARA) Manager - job post
Job details
Pay
- £55,000 - £60,000 a year
Job type
- Freelance
Location
Full job description
Role Overview
We are seeking an experienced QARA Manager for a 6-month contract to lead global regulatory compliance and quality assurance for our hardware product portfolio. Operating on a hybrid basis from our Cambridge office, you will collaborate closely with our internal engineering team and coordinate directly with our contract manufacturers. You will own the re-certification processes for CE, BIS, and UL, manage EMS and RoHS compliance, and ensure all existing products and New Product Introductions (NPI) meet stringent international standards.
Key Responsibilities
Regulatory Re-Certification & Compliance
- Lead and execute re-certification projects for existing hardware products, specifically focusing on CE, BIS, and UL marks.
- Maintain, update, and manage Technical Files, Declarations of Conformity, and regulatory documentation.
- Act as the primary point of contact for external test houses, notified bodies, and regulatory agencies.
Environmental & Materials Compliance
- Oversee and ensure full compliance with RoHS, REACH, and WEEE directives across all product lines.
- Manage Environmental Management System (EMS) requirements and alignment with relevant standards.
Lifecycle & Cross-Functional Collaboration
- Collaborate with the internal engineering team to retrieve technical drawings, schematics, and component data.
- Proactively monitor, analyze, and manage upcoming global regulatory changes impacting current products.
- Implement necessary engineering change orders (ECOs) to maintain continuous market compliance.
Supply Chain & NPI
- Travel to contract manufacturers to audit production compliance, resolve quality issues, and align on testing processes.
- Serve as the QARA lead on NPI teams to embed compliance requirements into early product design.
- Define compliance roadmaps, testing strategies, and certification schedules for new hardware launches.
Qualifications and Experience
- Experience: 5+ years in QARA roles within hardware, electronics, or manufacturing.
- Certifications: Proven track record securing and maintaining CE, BIS, and UL certifications.
- Standards Knowledge: Deep technical expertise in RoHS, REACH, and EMS frameworks.
- Collaboration: Experience partnering with internal engineering teams and managing contract manufacturers.
- Mobility: Willingness and ability to travel to contract manufacturing sites as required.
- Efficiency: Ability to operate autonomously and deliver results within a 6-month window
Pay: £55,000.00-£60,000.00 per year
Experience:
- QARA roles within hardware, electronics, or manufacturing.: 5 years (required)
- Deep technical expertise in RoHS, REACH, and EMS frameworks.: 3 years (preferred)
Work authorisation:
- United Kingdom (required)
Work Location: Hybrid remote in Cambridge (Cambridgeshire, East of England Region)