Senior Quality Systems Engineer

4 weeks ago


Cardiff, Cardiff, United Kingdom ATL Technology Full time
Job Description

Job Title: Senior Quality Systems Engineer

Job Summary: We are seeking a highly skilled Senior Quality Systems Engineer to join our team at ATL Technology. The successful candidate will be responsible for managing and improving quality systems processes to ensure EU and US regulatory compliance.

Key Responsibilities:

  • Regulatory Compliance: Ensure compliance with EU and US regulatory requirements, including the interpretation of relevant regulations and standards.
  • Quality System Management: Manage and improve quality systems processes to ensure effective working policies and procedures.
  • Internal Audits: Conduct internal and inter-company quality system audits, with responsibility for the audit process lifecycle.
  • Training and Development: Provide training and support to design and manufacturing teams on established procedures and quality systems.
  • Reporting and Analysis: Analyze data and provide reports to management to enable them to monitor system performance.

Requirements:

  • Qualifications: Diploma level Science/Engineering/Quality orientated qualification, Lead Auditor qualification (ISO 9000 series based quality system essential, ISO13485 preferred)
  • Experience: Minimum of 3 years' experience working in a QA/QS environment within the medical device or pharmaceutical industry.
  • Skills: Good analytical skills, experience of statistical techniques, computer literate to include MS Word and Excel and MRP, GMP and audit qualifications, supervisory experience.

Benefits:

  • Pension Scheme: Generous pension scheme
  • Bonus: Bonus
  • Life Assurance: Life assurance
  • Private Health Insurance: Private health insurance
  • Retailer Discounts/Cycle to Work Scheme: Retailer discounts/cycle to work scheme
  • Holiday: 33 days holiday (including bank holidays)
  • Hybrid Working: Hybrid working (role dependant)
  • Employee Assistance Programme: Employee assistance programme

About Us:

ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market. We believe there is a better way to bring medical devices to market, using an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life. It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.

We have operations in the UK, China, Costa Rica, Taiwan, UT-USA, plus remote staff in strategic global locations and we're growing.

We are an equal opportunity employer and welcome applications from all qualified candidates.



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