Senior Quality Engineer

Stack Digital; Blackpool; On-site; GBP 45,000 - 50,000

Job description

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