Quality Engineer based in Raynham MAAbout the RoleWe are seeking a proactive and detail-oriented
Quality Engineer to provide quality leadership and support across our operations, ensuring compliance with customer requirements, regulatory standards, and internal quality objectives.
This role is critical in driving continuous improvement, reducing quality costs, maintaining compliance with FDA and ISO standards, and supporting our commitment to
Safety, Quality, Customer Satisfaction, and Innovation. The successful candidate will work closely with cross-functional teams to enhance quality systems, support audits, investigate quality issues, and ensure the effectiveness of quality processes.
What you'll do:- Proactively investigate, identify, and implement best-in-class Quality Engineering practices.
- Develop quality assurance specifications, test methods, sampling plans, and associated procedures.
- Support CAPA activities, including investigations, root cause analysis, corrective actions, and effectiveness checks to ensure timely closure.
- Maintain and support the equipment calibration programme, including scheduling, record reviews, out-of-tolerance investigations, and audit support.
- Ensure compliance with ISO 13485 and MDSAP requirements related to calibration activities.
- Prepare for and support internal and external audits by coordinating evidence collection, supporting auditor interviews, and facilitating corrective action responses.
- Apply structured problem-solving methodologies to identify, prioritise, communicate, and resolve quality issues.
- Support non-conforming material processes and participate in MRB meetings to resolve product and process non-conformances.
- Provide technical guidance to QC Technicians regarding inspection activities and lead initiatives to improve product quality, reduce costs, and increase operational efficiency.
- Ensure compliance with quality system procedures across all areas of responsibility.
About YouTo be successful in this role, you will bring a strong quality engineering background within a regulated manufacturing environment, ideally medical devices.
Essential Qualifications & Experience- Bachelor's Degree in Engineering, Life Sciences, or a related discipline, or equivalent combination of education and experience.
- Strong working knowledge of medical device quality systems and regulatory requirements, preferably within the orthopaedic sector.
- Experience with:
- FDA 21 CFR Part 820
- FDA 21 CFR Part 11
- EN ISO 13485
- Medical Device Single Audit Program (MDSAP)
- Medical Device Directive 93/42/EEC
- Experience supporting CAPA, audit programmes, calibration systems, and non-conformance management.
- Working knowledge of supplier quality, product development, validation, and quality engineering principles.
Skills & Competencies- Strong analytical and problem-solving skills with the ability to identify root causes and implement effective solutions.
- Understanding of engineering dimensioning and tolerancing (GD&T), calibration methodologies, and inspection processes.
- Ability to interpret technical instructions, engineering drawings, and complex data sets.
- Excellent interpersonal and communication skills, with the ability to build effective working relationships across all levels of an organisation, as well as with suppliers and customers.
- Strong organisational skills with the ability to manage multiple priorities in a fast-paced environment.
- Advanced Microsoft Office skills, particularly in Excel, and experience working with quality databases and systems.
- Opportunity to work in a highly regulated and quality-driven environment.
- Be part of a collaborative team committed to continuous improvement.
- Contribute directly to the quality and safety of products that make a difference.
- Professional development and career growth opportunities.
- The base salary range is $85,000- $100,000k with a variable compensation package. The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set.
- Employee referral program where you can earn incentives for each successful hire you recommend
If you are passionate about quality, compliance, and driving continuous improvement within the medical device industry, we'd love to hear from you. Apply today and help us deliver products that improve patient outcomes worldwide.
