Senior Quality Engineer
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Job Summary
Job Description
Job title: Senior Quality Engineer
Salary: up to 45k other benefits
Location: Swansea
You will lead quality activities for new product introduction (NPI) ensuring our energy-based skin products are designed and manufactured to the highest quality safety and regulatory standards. Reporting to the Head of Quality you will manage the full APQP/PPAP process from design through to production release working closely with R&D Engineering Supply Chain and suppliers to ensure smooth product launch and scalable manufacturing.
Key Responsibilities
- Lead the full APQP/PPAP lifecycle for new products ensuring readiness for mass production.
- Manage key NPI quality activities including DFMEA PFMEA Control Plans FAIRs and production builds (IQ OQ PQ).
- Represent Quality in NPI project meetings.
- Develop and maintain quality standards instructions and documentation.
- Train teams on APQP core tools where required.
- Lead resolution of NPI quality issues including corrective and preventive actions.
- Investigate early market returns and support ECN reviews.
- Ensure production and warranty concerns (QC PMS HRC) are addressed early through Design for Quality (DFQ).
- Create visual appearance standards for products and packaging.
- Work with suppliers to ensure PPAP compliance and regulatory adherence.
- Maintain thorough documentation of all APQP/PPAP activities.
- Drive continuous improvement in APQP/PPAP processes.
- Ensure compliance with relevant regulatory standards (e.g. ISO FDA).
- Identify and mitigate product and supply chain risks.
- Provide regular performance updates to the Head of Quality.
Requirements:
- Proven hands-on experience delivering full APQP/PPAP lifecycle in a high-tech manufacturing environment (medical device or automotive preferred).
- Strong knowledge of manufacturing processes (injection moulding pressing PCBA/electronics packaging).
- High proficiency in APQP core tools: D/PFMEA MSA SPC PPAP DMAIC CAPA auditing.
- Strong leadership and cross-functional collaboration skills.
- Excellent communication skills (written and verbal).
- High attention to detail and data analysis capability.
- Able to challenge constructively and drive actions.
- Degree/HND/HNC in Electronic Mechanical or Production Engineering or Quality Management.
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Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
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