Quality EngineerDepartment: Quality
Reports To: Quality Manager
Salary Range: $80-$95,000 depending on experience
About the RoleWe are seeking an experienced
Quality Engineer to join our Quality team. This position plays a critical role in ensuring customer satisfaction, reducing internal scrap, driving continuous improvement initiatives, and supporting product and process validations. The ideal candidate is detail-oriented, analytical, and thrives in a fast-paced manufacturing environment while collaborating effectively with cross-functional teams.
Key ResponsibilitiesAs a Quality Engineer, you will:
- Develop and maintain quality plans, inspection plans, control plans, work instructions, and PFMEAs.
- Support new product introductions, product revisions, and process development activities.
- Participate in product qualifications, validations, and change control processes.
- Collaborate with Engineering to review drawings and ensure customer requirements are clearly defined and understood.
- Conduct measurement system analyses including GR&R studies and establish effective inspection methods.
- Lead or support Material Review Board (MRB) activities and nonconformance investigations.
- Manage customer complaints, CAPAs, NCMRs, and corrective action activities.
- Utilize quality tools such as Root Cause Analysis, FMEA, Risk Analysis, SPC, and 8D problem-solving methodologies.
- Perform internal audits and support external audits as required.
- Analyze process data and conduct process capability studies to drive continuous improvement.
- Train employees on quality requirements, inspection methods, and metrology practices.
- Support equipment validations and qualification activities in partnership with Maintenance, IT, and Operations teams.
- Drive initiatives to improve manufacturing quality, efficiency, and customer satisfaction.
Required Qualifications- Bachelor's degree in Manufacturing Engineering, Quality Engineering, or a related technical discipline, or an equivalent combination of education and experience.
- Minimum of 3 years of quality engineering experience in a manufacturing environment.
- Strong knowledge of quality systems, methodologies, and problem-solving tools.
- Experience with CAPA programs, process capability studies, GR&R, PFMEA, and SPC.
- Knowledge of ISO standards, preferably ISO 13485, and FDA regulations including 21 CFR Part 820.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office applications including Word, Excel, Outlook, and PowerPoint.
- Ability to work effectively in a cross-functional team environment.
Preferred Qualifications- ASQ Certification (CQE, CSQE, Six Sigma Black Belt, Lean, or equivalent).
- Strong GD&T knowledge and experience.
- Experience with Minitab.
- Experience using automated inspection equipment such as CMMs, Keyence, Vertex, or similar systems.
- Experience developing manufacturing quality plans and driving process optimization projects.
What We're Looking For- High energy and self-motivation.
- Strong attention to detail and accountability.
- Excellent analytical and problem-solving abilities.
- Effective interpersonal and communication skills.
- Ability to manage multiple priorities in a fast-paced environment.
- Commitment to continuous improvement and operational excellence.
Physical Requirements- Ability to sit, stand, walk, talk, and hear frequently throughout the workday.
- Regular computer use.
- Ability to lift up to 20 pounds occasionally.
