Quality Engineer / Quality Specialist – Medical Device

Quality Engineer – salary range is $30-50/hr, located in San Diego, CA. 

Are you a passionate Quality Engineer ready to make an impact with a tech-forward medical device company? Join and support a motivated team doing great work for the community.

Who you are:

• Bachelor’s Degree preferred in Biology or Sciences.
• 2+ years of professional experience in a related field, medical device industry preferred
• Understanding of ISO 13485 regulations and GMP regulations
• Understanding or internal and external audits supporting quality 
• Knowledge of FDA licensing
• Familiarity with Jother quality system regulations: CAPAs, NCMRs, Document control, preparing Quality documents, etc. 

What you’ll do:

• Assists and supports the organization in complying with, as well as the ongoing preparation, testing and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies.
• Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes.
• Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. 
• Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections.

Why work here:

• Collaborative environment: this is a team-centric, culture-oriented company with a focus on leveraging the unique skills of each worker
• Strong focus on innovation: independent self-starters will have the resources and support to quickly innovate
• Work that matters: perfect for someone looking to make an impact and help the community

Please email your resume to sboddy@provenrecruiting.com if you’d like to move forward in your career within a fast-growing division of an established company.

Note: We actively support and promote people of various backgrounds, from race, religion and gender to geographical area, university, lifestyle and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

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