Job Title: Senior Quality Engineer
Location: Blackpool, UK (Onsite)
Job Type: Permanent
Job Summary: Ensure the highest levels of quality, compliance, and regulatory adherence in product transfers and new technology implementations. Lead validation protocols, risk mitigation, and process improvements within a cross-functional, regulated medical device environment.
Key Responsibilities:
* Represent Quality in cross-functional teams to deliver projects on time with compliance.
* Develop and execute validation protocols for new products/processes/software.
* Ensure correct implementation of validation procedures and re-validate as needed.
* Apply statistical analysis during validation and define production controls.
* Utilize DFMEA/PFMEA to minimize development/implementation risks.
* Collaborate with R&D to document Critical to Quality Characteristics.
* Lead Design for Inspection/Manufacture initiatives to reduce human error.
* Ensure compliance with FDA QSR’s, ISO 13485/9001, and other regulations.
* Conduct root cause analysis, complaint investigations, and corrective actions.
* Assist in reducing compliance risks, scrap, and reprocessing.
* Review and approve product, tooling, and fixture drawings.
* Adhere to Health, Safety, and Environmental guidelines.
* Report issues to Client and TCS management and maintain performance metrics.
* Perform additional duties as assigned.
Key Requirements:
Essential:
* Bachelor’s degree in Engineering (Manufacturing/Mechanical/Production) or equivalent. Advanced degrees in Science, Computer Science, or digital fields may be considered.
* Proven Quality Engineering experience in MedTech, Pharmaceutical, or regulated industries.
* Track record of successful product launches in Medical Devices.
* Expertise in risk mitigation, Process Mapping, Equipment Qualification, and Test Method Validation.
* Strong knowledge of MDSAP, MDD, MDR, FDA, and ISO standards.
* In-depth understanding of Product/Process Risk Management.
* Proficiency in statistical analysis, project management, PLM, and MS Office.
* Excellent communication, teamwork, and problem-solving skills.
Desirable:
* Experience in Process/Manufacturing Quality.
* Familiarity with GD&T, Six Sigma, Lean Manufacturing, or Continuous Improvement.
Other Information:
* Work Policy: Mandatory 5 days/week onsite at client location. Candidates must be based in or near Blackpool.
* Salary Range: Up to £45,000 - £50,000 per annum.
* Hours: 40 hours/week (full-time).
Seniority Level:
Mid-Senior level
Employment Type:
Full-time
Job Function:
Quality Assurance
Industries:
IT Services and IT Consulting
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