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Top Echelon Network
Quality Engineering Manager
Job Location: Sunnyvale, CA
Responsibilities:
Ensures implementation and compliance of the Quality System to FDA QSRs, MDD, ISO 13485:2003 and other relevant international regulations.
Assigns resources to support company quality initiatives.
Lead QEs in PDP efforts.
Ensure products comply with marketing and quality system requirements.
Collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers.
Ensure that compliance to cGMP and EN/ISO 13485:2003 /MDD/Canadian and other international regulations and standards are maintained.
Ensure that all the responsibilities within the scope of this job comply with the scope of the Quality System.
This position will manage Quality Engineers
Requirements:
Requires a team player with a bachelors degree in engineering or life sciences and 4 to 10 years experience, or an AA and equivalent work experience totaling more than 12 years in the medical device industry. Masters degree in Quality or Business preferred.
Minimum of 2 years management experience.
Must be able to make decisions related to product quality and release of products.
Requires ability to assess current practice with external standards, guidance, and regulations.
Must be able to provide and implement solutions to quality problems.
Requires the ability to understand the impact of GMPs, ISO 13485:2003, Canadian, Japanese and other international standards, and MDD requirements on products
Click Here to Apply
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