Michael Page
- Growth Plan to become Quality Director
- Company-paid Lean Six Sigma Certification
My client is a leading contract manufacturer focused on precision injection molding for the medical, pharmaceutical, and life sciences industries. Known for delivering high-quality, compliant components, they support a range of customers in highly regulated sectors. They are based out of Naugatuck, CT.
Job Description
The Quality Engineer will:
- Ensure compliance with ISO 13485 and FDA 21 CFR Part 820 in a regulated manufacturing environment
- Lead and support quality investigations, including root cause analysis, CAPA, and non-conformances
- Support and participate in equipment and process validations (IQ/OQ/PQ)
- Collaborate with engineering and production to resolve product and process quality issues
- Develop and implement inspection procedures, quality plans, and related documentation
- Analyze data using tools like Minitab to monitor trends and drive continuous improvement
- Contribute to new product introductions by supporting quality planning from prototype to production
- Oversee supplier quality activities including audits, incoming inspection, and corrective actions
- Design and improve gauges, fixtures, and vision system setups for quality assurance
- Apply statistical methods such as SPC, FMEA, and MSA in daily quality activities
- Support internal and external audits, including regulatory and customer inspections
- Participate in Lean and Six Sigma initiatives, with on-site training and certification opportunities
The Successful Applicant
The succesful Quality Engineer will:
- Strong background in plastic injection molding and metrology.
- Proficient in reading complex part prints and applying geometric tolerancing (GD&T).
- Experience with SPC, SQC tools, and statistical data analysis.
- Knowledge of ISO 9001 and ISO 13485 quality management systems.
- Strong organizational, problem-solving, and communication skills
On Offer for the Quality Engineer candidate is:
- Mentorship and on-site Six Sigma training from a Certified Master Blackbelt, with company-sponsored certification
- Competitive salary and compensation package
- Performance-based bonus opportunity
- Comprehensive benefits package including medical, dental, and vision coverage
- 401(k) plan with employer matching contributions
- Paid time off
- Supportive and collaborative team culture within a stable and growing organization
- Exposure to a variety of quality engineering responsibilities in a regulated manufacturing setting
- Flexible start times to accommodate different work/life needs
APPLY TODAY! You dont want to miss out on this opporunity for growth!
Contact
Megan Obrien
Quote job ref
JN-072025-6780013