Senior Quality Engineer (Medical Device) Job at Tek Support, North Haven, CT

c082NGsrTVQ0dngxMHZ5MmJLcVgzTkxBYWc9PQ==
  • Tek Support
  • North Haven, CT

Job Description

Experience : 8–10 years minimum

Job Summary

Seeking an experienced Quality Engineer to support medical device manufacturing through validation, process improvement, and compliance activities. The ideal candidate will have a strong background in quality systems, validation (IQ/OQ/PQ), root cause analysis, and cross-functional collaboration.

Key Responsibilities

  • Drive quality improvements in product cost, process, and compliance.
  • Support DFM/DFA activities and manufacturing validations (IQ, OQ, PQ, MSA).
  • Conduct RCA, NCR, CAPA and execute process improvements.
  • Lead equipment and process testing, validation, and PFMEA.
  • Apply statistical tools (SPC, SQC, DOE) for quality assurance.
  • Manage CDPs, SAT/FAT, and validation gap analyses.
  • Collaborate with cross-functional teams on production floor troubleshooting.
  • Support documentation, process updates, and material disposition.

Qualifications

  • BS in Packaging Science, Mechanical, or equivalent Engineering.
  • 8 years in packaging/quality engineering in medical devices or pharma.
  • Strong knowledge of validation, quality systems, and manufacturing processes.

Job Tags

Similar Jobs

Brooksource

Deviation Investigator Job at Brooksource

 ...Deviation Investigation Support Operations Location: On-site in Concord, NC Engagement Type: 612 month contract (with potential...  ...potential for extension, ideal for professionals with 35 years of experience in technical writing, root cause analysis, and quality... 

New York Dental

Full Time Dental Receptionists and Administrative Assistant Job at New York Dental

Full Time dental receptionists and administrative assistantNew York Dental is looking for a full time front desk receptionist and administrative assistant 1) BS degree or above 2) Fluent in English (Speaking and Writing) 3) Minimum 2 years of working experiences. 5) Disciplined... 

Helios

Creative Director - Founding Team Member Job at Helios

Creative Director Founding Team Member About Us Helios is building the AI-native OS for government interaction. Our first product, Proxi, is already redefining how policymakers, lobbyists, Fortune 500s, and public servants navigate power. We're automating the workflows...

Confidential

Director of Nursing Job at Confidential

 ...The Opportunity The Director of Nursing is part of the Clinical Team and will be responsible in overseeing the comprehensive care provided to our Patients. This pivotal role ensures high standards of care and ensures compliance with all regulatory requirements. This leadership... 

Solü Technology Partners

Mortgage Loan Processor Job at Solü Technology Partners

 ...Responsibilities Review each loan file to verify that documents are present, accurate, and complete before underwriting Manage loan process through mortgage software system Ensure that loan rules, obligations, and deadlines are met Audit and prepare quality...