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Sr. Quality Engineer - ISO 13485
ISO 13485 experience
Small medical device company, hands on type of position
About Our Client
Our client is an industrial manufacturing company located in southern NH. They are currently looking to hire a Sr. Quality Engineer to join a small medical device manufacturing company that can wear many hats and be entrenched in the day to day of production from a quality standpoint.
The Sr. Quality Engineer - ISO 13485 will have responsibilities that include:
- Work with all departments, especially production, to ensure quality of product is met.
- Work directly with quality systems to ensure compliance to ISO 13485.
- Interface with governing bodies including ISO and FDA in conjunction to Quality and organizational leaders.
- Interfaces with product design and development engineers and production.
- Perform routine mechanical, dimensional, and electrical testing and analysis of results on in-process product, finished product and incoming supplier product.
- Manages calibration program, calibrates test equipment within capabilities and confirms measurement adequacy through Gage R&R studies.
- Reviews and recommends disposition of non-conforming material.
- Initiates and manages CAPA / SCAR processes.
The Successful Applicant
The Successful Sr. Quality Engineer - ISO 13485 will have:
- Bachelor's degree required in Engineering, Mathematics or related field.
- 3+ years of relevant work experience within a medical device manufacturing company.
- Experience with ISO 13485 quality systems.
- Strong interpersonal skills.
- Strong communication skills.
- Ability to wear multiple hats.
What's on Offer
- Established quality department and organization
- Career development and training
- Work/life balance