Job Title: Quality Assurance Engineer
Location: North Haven, CT (100% Onsite)
Experience: 6+ years
Duration: 12+ Months Contract
We are seeking a Quality Assurance Engineer to join our Surgical Instruments team, supporting new product development. This role partners with cross-functional teams to ensure product quality, compliance, and continuous improvement. The ideal candidate brings expertise in mechanical and electromechanical design, design verification/validation, process validation, risk management, and complaint analysis within a regulated environment.
Key ResponsibilitiesActively participate in product development by reviewing design documentation, performing risk assessments, and defining verification and validation testing requirements.
Drive product risk assessments through tools such as risk management plans/reports, hazard identification, risk analysis charts, and complaint analysis.
Collect, analyze, and interpret statistical data; prepare reports and recommendations for management.
Support design and process validation initiatives, including oversight of system/sub-system requirements, CTQ matrix, process flows, control plans, MSA, and process capability analyses.
Ensure consistent use of quality engineering tools across projects.
Develop and implement solutions for complex engineering challenges aligned with organizational objectives.
Bachelor's degree in Engineering, Math, Physical Science, or related field.
5+ years of experience in engineering or quality (or 4+ years with Master's degree).
Experience in a regulated industry (medical devices preferred).
Strong foundation in electro-mechanical design and manufacturing processes.
Proficiency with statistical analysis tools (e.g., Minitab).
Experience with risk management tools and methodologies.
Excellent organizational, analytical, and problem-solving skills.
Ability to work independently and in a team environment, balancing multiple projects.
Strong written and verbal communication skills.
6+ years of experience in a regulated industry (advanced degree may substitute for 2 years).
ASQ Certified Quality Engineer (CQE).
Knowledge of medical device regulations and standards, including FDA QSR, ISO 13485, ISO 14971, and IEC 60601.
Experience with software/hardware interfaces.
Strong project management skills with the ability to prioritize effectively.
...higher-level staff. Possesses beginning to working knowledge of subject matter. Education: (minimum education required)~ High School Graduate. Skills and Minimum Experience Required: Basic math and computer skills. Typically reports to a shift supervisor...
...Stylist - PT - Belmont Outlet Belmont, Elmont, New York THE ALLSAINTS TEAM At AllSaints we are in the business... ...will also support handling first line customer enquiries via our online customer service system, with the remainder of your time being...
2nd shift cleaner from 5pm-10:30pm Must have experience performing all duties of a general cleaner. Emptying trash, dusting, vacuuming... ...and light industrial cleaning in Northern KY Job Type: Part-time Paid Bi Weekly Apex Environmental Services, LLC offers over...
...Medical Dental Vision Discount Simple IRA HSA Company paid life insurance and long-term disability. PTO Requirements: Looking for major account representatives as well as entry level Valid driver's license with acceptable driving record that would...
**NOW HIRING ASSEMBLERS!**Are you hands-on, detail-oriented, and looking to join a company that values hard work and family? We're hiring **Assemblers** to join a growing team in Salisbury... ...of providing an accessible and barrier-free environment. We are committed to creating...