Process/Manufacturing Engineer - Quality

Norman Noble is a renowned, privately-held contract manufacturer of life sustaining medical devices that help to improve or save lives. Our reputation for excellence and our outstanding team have been providing service to our customers for nearly 80 years.

Our state-of-the-art facilities support innovative solutions where we manufacture, finish and inspect medical device implants for customers worldwide.

The Quality Engineer works with internal teams, suppliers and customers to analyze data, develop solutions and make recommendations and decisions to support and improve manufacturing processes.

Responsibilities and Duties:

• Work with manufacturing to solve quality concerns and review, evaluate, and disposition non-conforming product
• Analyze data and apply appropriate statistical tools to solve issues and determine outcomes.
• Communicate (verbal and written) with customers and suppliers.
• Aid in the maintenance and control of the quality management system specifically quality system documents (internal and external), quality system records, device history records, and final product release.
• Works with Customers, Sales, and Engineering on validation & quality planning activities for new or existing programs.
• Reviews drawings and recommends inspection and gauging methodology on new or existing programs.
• Performs supplier quality audits (on-site and virtual).
• Works as part as Supplier Quality Team to assess and evaluate existing suppliers for quality and performance, and to qualify new suppliers through evaluations, audits, and surveys
• Coordinates 3rd party testing as part of regularly occurring testing on sampling basis.
• Performs validation activities as part of supplier qualifications and changes.

Skills and Experience:

• 3-5 years full time (not including co-op) process, manufacturing, and/or quality engineering experience in med device, aerospace, or automotive manufacturing
• Bachelor's degree in engineering or related field required
• CAPA experience/knowledge required, preferably in contract manufacturing or machining industry
• Understanding of SPC, FMEA, DOE, inspection methods and equipment
• Experience preparing, coordinating and executing validation activities including: IQ, OQ, PQ, SRS and MSV
• Experience with QSRs, DHRs and final product release preferred
• Knowledge of ISO 9001, 13485 and FDA QSR
• Strong analytical, project management and problem-solving skills
• Organizational skills and have demonstrated ability to meet deadlines in fast-paced environment
• Proficiency in Microsoft Office, with advanced proficiency in Excel
• ASQ, CQT, CQA and/or CQE certification is a plus

Why Work at Norman Noble?

Our employees enjoy an entrepreneurial work experience where everyone’s contributions are important and visible. Manufacturing facilities are state-of-the-art, clean, lab-like and provide the tools and resources needed to be successful. Continuous growth is developed through collaborative project work, high tech problem-solving and interaction with customers and key internal stakeholders. We offer an outstanding comp/benefits package that we welcome the opportunity to discuss.

Norman Noble, Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of age, gender, gender identity or expression, sexual orientation, marital status, race, color, ethnicity, religion or creed, national origin, citizenship, disability, veteran status, political affiliation, or any protected characteristics as required by federal, state, or local law. We are committed to the inclusion of qualified individuals, including those with disabilities who require reasonable accommodation to perform essential job functions.