Quality Engineer
Posted Today by Hyper Recruitment Solutions
Negotiable
Undetermined
Undetermined
Cambridgeshire, England, United Kingdom
Summary: The Quality Engineer, Compliance role at a leading biotherapeutics pharmaceutical research and development centre in the UK focuses on supporting innovative medical device and combination product development projects. The position requires a proactive professional to ensure regulatory compliance, design control, and risk management throughout the product lifecycle. The role involves collaboration with cross-functional teams and external partners to uphold quality standards in a fast-paced, regulated industry. This opportunity is vital for advancing life-changing therapies.
Key Responsibilities:
- Lead design control and risk management activities for combination product development programs.
- Support and facilitate effective risk management activities at external design companies and manufacturing facilities.
- Ensure compliance of combination product development activities with quality and regulatory standards.
- Provide input and support to design validation, including human factors engineering assessments.
- Support device design and manufacturing investigations from clinical trials and commercial manufacture.
- Assist in generating regulatory submission data and content for assigned device projects.
- Collaborate with cross-functional teams to uphold quality standards across all project phases.
Key Skills:
- A Degree or higher level in science or engineering (e.g., Biomedical Sciences, Mechanical Engineering, Materials Sciences, Chemical Engineering).
- Proven relevant experience in the pharmaceutical combination product and/or device industries.
- Experience working in accordance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulation.
- Familiarity with design controls, risk management, and Human Factors Engineering related to medical devices.
Salary (Rate): undetermined
City: Cambridgeshire
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
We are currently looking for a Quality Engineer, Compliance to join a leading biotherapeutics pharmaceutical research and development centre of excellence based in the UK. This is an exciting opportunity for a proactive and detail-oriented professional to contribute to innovative medical device and combination product development projects throughout their lifecycle. The role offers a dynamic environment where your expertise will support regulatory compliance, design control, and risk management activities, ensuring quality standards are met at every stage. This position provides a unique chance to work within a collaborative team, interacting with cross-functional stakeholders and external partners, while influencing the success of cutting-edge healthcare solutions. Join our client to play a vital part in advancing life-changing therapies in a fast-paced, regulated industry.
KEY DUTIES AND RESPONSIBILITI ESYour duties as the Quality Engineer, Compliance will be varied however the key duties and responsibilities are as follow s:
- As the Quality Engineer, you will lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensure s.
- As the Quality Engineer, you will support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned project s.
- As the Quality Engineer, you will ensure combination product development activities are compliant with quality and regulatory standards, both internal and externa l.
- As the Quality Engineer, you will provide input and support to design validation, including human factors engineering assessment s.
- As the Quality Engineer, you will support device design and manufacturing investigations from devices used in clinical trials and commercial manufactur e.
- As the Quality Engineer, you will support the generation of regulatory submission data and content for assigned device project s.
- As the Quality Engineer, you will collaborate with cross-functional teams to ensure quality standards are upheld across all project phase s.
ROLE REQUIREM ENTSTo be successful in your application to this exciting role as the Quality Engineer, Compliance we are looking to identify the following on your profile and past hist ory:
- A Degree or higher level in science or engineering (e.g., Biomedical Sciences, Mechanical Engineering, Materials Sciences, Chemical Engineering) with proven relevant experience in the pharmaceutical combination product and/or device industr ies.
- Experience working in accordance with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and EU Medical Devices Regulat ion.
- Familiarity with design controls, risk management, and Human Factors Engineering related to medical devi ces.
Key Words: Quality / Engineering / Quality Engineering / Quality Assurance / Quality Compliance / Medical Device Quality / Combination Products / Device Quality / Risk Management / Design Control / Design Controls / Design History File / DHF / Risk Assessment / Risk Analysis / Risk Mitigation / ISO 13485 / ISO 14971 / ISO 9001 / 21 CFR 820 / 21 CFR Part 4 / EU MDR / Medical Device Regulation / Regulatory Compliance / Regulatory Standards / Quality Management Systems / QMS / GMP / Good Manufacturing Practice / Human Factors / Human Factors Engineering / Usability Engineering / EN 62366 / EN 60601 / EN 62304 / Design Validation / Design Verification / Product Development / Product Lifecycle / Device Development / Device Manufacturing / Supplier Quality / Supplier Qualification / Supplier Audits / External Manufacturing / Combination Product Development / Medical Device Development / Clinical Devices / Design Reviews / Technical Documentation / Regulatory Submissions / Audit Support / Internal Audits / External Audits / Investigation / Root Cause Analysis / CAPA / Continuous Improvement / Cross Functional Collaboration / Stakeholder Collaboration / Technical Documentation / Product Innovation / Engineering Support / Compliance / Quality S ystems
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your c areer."