Quality Engineer ATS Automation Tooling Systems Inc.
Overview
Lead Quality Engineer supporting Comecer Project Managers overseeing orders from a quality perspective across design reviews, FAT, SAT, IQ, OQ, and PQ within the VPHP cycle development. Service markets include Radiopharma Pharma and Cell & Gene Therapy projects in North America such as shielded hot cells synthesis modules LAF isolators and VPHP sterilization systems. Responsibilities encompass drafting technical documents interpreting regulations managing orders through validation processes collaborating with internal and external teams to execute SAT IQ OQ and VPHP activities while maintaining compliance with standards. This role differs by focusing on end-to-end product lifecycle support for advanced therapy applications.
What You'll Do9
- 1Support design reviews and field testing including SAT IQ OQ and VPHP cycle development
- 2Draft and finalize technical documentation while applying legal regulatory and project requirements
- 3Collaborate with internal teams and third‑party vendors to perform field inspections and validate processes
- 4Develop inspection methods to analyze product quality and implement systems ensuring production conformity
- 5Ensure compliance with ISO 9001 standards and customer specifications through corrective actions
- 6Plan and document control activities and inspections to maintain accurate manufacturing processes
- 7Communicate efficiently with stakeholders at all organizational levels
- 8Solve complex problems using strong analytical skills and proficiency in Microsoft Office
- 9Stand, walk, push, pull, reach overhead and bend to the floor while meeting deadlines
Requirements6
- 1Bachelor’s degree in a technical field or equivalent experience with quality engineering focus preferred
- 2Experience with ISO 9001 standards preferred
- 3Ability to read written instructions and computer screens with normal visual acuity
- 4Normal hearing for understanding verbal instructions
- 5Physical stamina to wear PPE for extended periods
- 6Hands‑on capability to meet project deadlines
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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