Quality Engineer – CAPA Training Specialist

Carlsbad, California

Work Arrangement: Hybrid
2021-11-16

Quality Engineer

Are you looking for a new challenge to join a high caliber team with an exciting San Diego company? This company grew from 0 to $2B in revenue in 12 months and is looking to continue with this explosive growth. They are looking to add a qualified and motivated Quality Engineer to their team. In this role, you will have the opportunity to partner with a global team, build things from scratch, and master new challenges while working with engaged peers who enjoy their work. Don’t miss the chance to contribute to an outstanding culture. Apply today!

What you’ll do

  • Maintain an effective Quality Management System in compliance with global regulatory requirements including but not limited to ISO 13485:2016, MDSAP, National Medical Products Administration (NMPA) in China, and other international markets as determined by business objectives.
  • Oversee all functional areas of the QMS including: Personnel Training, Qualification and Competency, Document and Record Controls, Corrective and Preventive Action
  • Maintain a program for internal Quality System training and provision of annual GMP training.
  • Ensure standardization exists between operations in all facilities for Document Management, CAPA and Training Systems.

Who you are

  • Bachelor’s degree in Engineering, Biological Science or related technical discipline, or equivalent experience.
  • 5+ years’ experience in Quality for a medical device or in-vitro diagnostic company, required.
  • Must have a broad background of QMS activities in all Document Management, CAPA and Training

Why work here

  • Supportive leadership & team: you’ll work with an intelligent, productive, appreciated and supportive team who enjoy and has a reputation for mentoring and developing others with a drive for success.
  • Competitive package: this role offers base, bonus, equity, and benefits.
  • High-growth environment: this company is rapidly expanding and is looking for people who can grow with them.

 

Please email your resume to sshields@provenrecruiting.com if you’d like to work alongside some of the finest professionals in the Life Sciences Industry!

 

Note: We actively support and promote people of various backgrounds, from race, religion, 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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