Quality Engineer II
Responsibilities
- Join our Quality Assurance team in Spiddal as a hands-on Quality Engineer II, supporting manufacturing, validation, audits and continuous improvement to ensure compliant, high-quality medical devices.
- Ensure customer and regulatory requirements are clearly defined, documented and embedded into manufacturing processes, maintaining compliance with the Quality Management System and applicable standards.
- Develop, review and maintain effective incoming, in-process and final inspection plans, making product disposition decisions and updating specifications and visual standards as required.
- Lead investigations into product and process quality issues, including customer complaints, driving timely and effective resolution through the CAPA system and assessing deviations, reworks and manufacturing changes for impact on product quality and validation status.
- Lead and support process validations in line with customer and internal requirements, including authoring and approving validation protocols, reports and test documentation.
- Review and approve manufacturing procedures, CHRs, purchasing specifications and inspection standards.
- Act as Lead Quality Auditor, conducting supplier quality audits and supporting customer and regulatory inspections.
- Analyse process performance data to identify trends and drive continuous improvement initiatives.
- Supervise and support assigned team members and contribute to project teams, delivering agreed milestones to schedule and budget.
Qualifications
- Degree or Diploma in Engineering, Science, Quality or equivalent experience in a Quality Assurance role within the Medical Device industry.
- Minimum of 5 years’ experience in a similar quality engineering role.
- Proven experience supervising or leading small teams
- Strong working knowledge of ISO 13485, FDA and related regulatory standards.
- Demonstrated problem-solving capability with Six Sigma Green Belt (or higher) certification.
- Understanding of Lean principles; Lean Green Belt is an advantage.
- Excellent attention to detail with strong analytical, communication and decision-making skills.
- Proactive, adaptable and comfortable working with minimal supervision.
- Must be able to work under own initiative, with minimum supervision.
The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.
