Sr Quality Engineer

195 McDermott Road North Haven, CT 06473 US

Posted: 09/25/2025 2025-09-25 2025-10-26 Employment Type: Contract Job Category: Quality and Compliance Job Number: 622791 Is job remote?: No Country: United States

Job Description

Pay 45-60/h depending on experience

Top 3 technical skills that are required for the role:

1. Risk Management (Hazard Analysis, DFMEA, UFMEA)
2. Design Verification Authoring and Execution
3. General NPD QE skillset. (Change control, CAPA, Iso 13485 understanding)

Education Required: Bachelors of Engineering

Years’ Experience Required: 4

Careers that Change Lives

A Day in the Life

The Senior Quality Engineer position on the team supports new product development for Surgical Instruments. In this role, the Senior Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of mechanical and electromechanical design, design verification, design validation, process validation, risk management and complaint analysis is preferred. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.

POSITION RESPONSIBILITIES MAY INCLUDE THE FOLLOWING AND OTHER DUTIES MAY BE

ASSIGNED:

• Actively participate in product development cycle by reviewing mechanical/electromechanical project documentation, participating in product risk assessments, and working closely with Product Development to develop appropriate verification and validation testing requirements.
• Assesses overall product risk by facilitating the development of risk management tools such as the risk management plan/report, hazard identification, risk analysis chart, complaint analysis, etc.
• Collect, analyze and interpret statistical data. Performs analyses and provide reports to management as required.
• Contributes to the successful completion of Design and Process Validation initiatives by planning/reviewing validation and qualification activities, as required. This may include oversight to System/Sub-system Requirements, Critical to Quality Matrix, Process Flows, Control Plans, Measurement Systems Analyses and Process Capability Analyses.
• Assisting with projects and assuring proper and consistent implementation of the

quality engineering tools.

• Provide solutions to a wide range of difficult challenges. Work independently to

determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.

Embedded Responsibilities:

• Excellent organizational and communication (oral and written) skills. Ability to work on teams as well as individually. Able to set and meet goals. Organized and detail oriented. Problem solving and analysis skills.

BASIC QUALIFICATIONS:

MUST HAVE: MINIMUM REQUIREMENTS:

EDUCATION REQUIRED:

• B.S. degree in Engineering, Math, Physical Science, or equivalent field with 5+ years of work experience in engineering or Quality
• Preferred: M.S. degree in Engineering, Math, Physical Science, or equivalent field with 4+ years of work experience in engineering or Quality

YEARS OF EXPERIENCE:

• Nice to Have: 6+ years of experience in a regulated industry (2+ years of experience can be substituted for an Advanced degree in a related discipline)

SPECIALIZED SKILLS OR EXPERIENCE:

• Fundamental understanding of electro-mechanical designs and manufacturing

processes to support designing, troubleshooting, improving and qualifying the design to ensure the sustainable manufacturing of medical devices both internal and external.

• Experience in a regulated industry
• Experience with Minitab or similar statistical analysis tools
• Experience with Risk Management Tools
• Good interpersonal skills; Ability to work effectively in a team environment and build strong working relationships.
• Ability to work in a fast-paced environment; Ability to work well under pressure and maintain positive, enthusiastic attitude
• Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
• High degree of initiative and self-motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.

NICE TO HAVE

• ASQ Certified Quality Engineering (CQE)
• Knowledge of and experience in developing and manufacturing medical devices in conformance with Quality System Regulations, ISO13485, 14971 and 60601 requirements
• Understanding of software and hardware interface

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

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