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Quality Engineer 2- Medical Equipment- Rochester NH

Rochester, New Hampshire Permanent USD90,000 - USD110,000 per year View Job Description
Join a dynamic team as a Quality Engineer II, where you'll lead continuous improvement initiatives in the design and manufacturing of innovative medical devices. You'll work closely with engineering and manufacturing to ensure quality standards, drive problem-solving for non-conformances, and play a key role in enhancing product precision through testing and validation processes.
  • In house end-to-end solutions
  • Competitive Base Salary + Benefits

About Our Client

This dynamic contract manufacturing organization brings over 25 years of expertise in assembly, packaging, and sterilization, serving diverse medical sectors such as orthopedic, cardiovascular, diagnostic, and dental industries. With a unique end-to-end service model, the company offers in-house solutions backed by deep regulatory knowledge, delivering exceptional agility and flexibility to accelerate product launches, streamline supply chains, and minimize risks, making them a trusted partner for companies seeking efficient, reliable, and high-quality manufacturing solutions.

Job Description



  • Develop, modify, and maintain quality standards and protocols for processing materials into finished products


  • Design, document, and implement QA procedures to ensure compliance with regulatory standards


  • Collaborate with engineering and manufacturing teams to uphold quality standards


  • Conduct analytical investigations and root cause analysis for non-conformances


  • Create and implement inspection methods and testing procedures for product and equipment precision


  • Design inspection and testing mechanisms, conduct QA tests, and perform statistical analysis to assess product quality


  • Write protocols, analyze data, and generate reports for product verifications and validations


  • Administer the e-QMS system and document control processes


  • Interface with vendors and customers to ensure smooth operations


  • Participate in MRBs, pFMEA, risk management reviews, and CAPAs to ensure compliance and reliability


  • Specialize in areas like design, material control, product evaluation, and R&D for process quality


  • Conduct supplier evaluations and audits to ensure high-quality standards


  • Review lab results, approve product releases, and provide backup for inspection and testing


  • Collaborate in a fast-paced team environment and assist with customer audits as needed

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant



  • BS or MS in Engineering or related scientific discipline with 2-4 years of experience in medical device manufacturing (Class I & II)


  • 3 years in the medical device industry, with a focus on microbiology and sterilization preferred


  • Experience in design control, process validation, failure investigations, root cause analysis, and applying statistics for quality assurance


  • Participated in FMEAs or other risk assessment activities


  • Experience supporting FDA and certified body audits is a plus


  • Clean room manufacturing experience preferred


  • Strong team player with excellent communication, interpersonal, and presentation skills


  • Ability to interpret safety rules, operating manuals, drawings (GD&T), and procedures


  • Strong skills in computer usage, math, writing, and problem-solving


  • Proficient in statistics (Cpk analysis, Gage R&R, tolerance analysis, and sample size selection); intermediate Minitab skills


  • Solid understanding of GMP, ISO 13485, FDA QSR, ISO 14971, and medical device compliance standards


  • Knowledge of lean and six sigma principles; Green Belt preferred


  • High energy, strong organizational skills, and attention to detail in a fast-paced environment


  • Ability to work independently, take initiative, and deliver exceptional customer service


  • Excellent verbal and written communication skills



What's on Offer

Work here for the opportunity to be part of a fast-paced, innovative environment where their contributions directly impact the development of cutting-edge medical devices. With a focus on continuous learning, professional growth, and collaboration, employees can gain valuable experience in quality assurance, process improvement, and regulatory compliance. The company values initiative and offers a supportive, team-oriented culture, making it an exciting place to grow your career while making a real difference in healthcare and product development.

Contact
Carlie Goodwin
Quote job ref
JN-042025-6713173

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Quality, Technical
Industry
Industrial / Manufacturing
Location
Rochester
Contract Type
Permanent
Consultant name
Carlie Goodwin
Job Reference
JN-042025-6713173