SR. Quality Engineer

3 weeks ago


Berlin, United States Insight Global Full time

Our medical device manufacturing client is looking for a Senior Quality Engineer to join their team in Berlin, CT This individual will support operational and process qualifications for customer manufacturing processes in cooperation with cross-functional engineering teams. They will provide direction in implementing and continuously improving Incoming Inspection, First Article Inspection, In-Process and Final Product Inspection plans. They will also conduct audits for internal manufacturing processes to ensure compliance with work instructions, summarize findings, outline opportunities for improvement, and proactively identify potential nonconformances. This person will also need to provide statistical data/trending analysis develop and oversee equipment qualification and process validation plans and lead continuous improvement projects based on process/product trends, customer complaints, industry standards and government regulations. This is an exciting opportunity to lead at a growing company with high visibility and exposure to clients and projects on an end to end basis Quality certification(s) (e. g. ASQ CQE, QCI, etc.). Class I, II and/or III Medical Device manufacturing experienceBachelors in Engineering or transferrable industry work experience 4-6 years in a regulated manufacturing environment (Medical Device, Aerospace, Defense, Pharmaceuticals, etc.) "Hands-on" self-starter with ability to work both independently and as part of a team1-2 years Leadership/Supervisory-level experienceStrong verbal and written English language communication skills.



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