Bonney Staffing

Reporting to the Director of QA/RA, the Quality Engineer, in Somersworht, NH oversees the continuous improvement of medical devices, along with the design and manufacturing of new devices. Responsibilities include developing prototypes, assessing manufacturing standards' quality, and establishing guidelines for technological enhancements.

Quality Engineer Responsibilities:

• Develop, document, and implement QA procedures.

• Interpret and assess conformity to regulatory standards.

• Provide analytical investigations and root cause development for non-conformance.

• Design and specify gauging and test equipment for quality assurance.

• Write protocols, analyze data, and generate summary reports for verification and validations.

• Lead and participate in design control projects for new and evolving medical devices.

• Interface with vendors and customers as needed.

• Conduct design reviews, pFMEA, risk management reviews, validations, CAPAs, NCMRs, etc.

• Conduct supplier evaluations, qualifications, and quality audits.

• Review all lab results and approve product release.

• Collaborate within the Quality Department and with Medical personnel in a team environment.

• Assist in Supplier Quality Audits and act as backup for inspection and test activities.

• Participate in Customer Audits as required.

Quality Engineer Qualifications:

• Bachelor's or Master's degree in Engineering or related scientific discipline.

• 5-7 years of experience in manufacturing medical devices/disposables (Class II).

• Preferred 3 years of experience in the Medical Device industry.

• Certification as a Quality Engineer or Quality Auditor (ASQ) is desirable.

• Experience with design control, process validation, failure investigations, root cause analysis, and statistical application to quality assurance.

• Experience participating in FMEAs or other risk assessment activities.

• Familiarity with supporting FDA and certified body audits.

• Clean room experience is advantageous.

• Team player with excellent communication, interpersonal, and presentation skills.

• Proficient in reading and interpreting safety rules, operating procedures, drawings, and manuals.

• Strong computer, math, writing, and problem-solving skills.

• Expert understanding of GMP, ISO 13485, FDA QSR for medical devices, ISO 14971, and device-related compliance standards.

• Knowledge of lean manufacturing principles.

Skills and Abilities:

• High energy level and strong verbal and written communication skills.

• Organized with exceptional record-keeping and follow-up abilities.

• Commitment to delivering exceptional customer service, both internally and externally.

• Attention to detail in a fast-paced environment.

• Ability to work independently and take initiative.

• Excellent interpersonal and communication skills.

Quality Engineer Details: 

• Pay Rate: $92K-$100K/year

• Full-Time: Monday-Friday

• Shift: 8 am - 5:00 pm

If you believe you are a qualified candidate for our

Quality Engineer please apply or contact us today!

Benefits:

• Full benefits package

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