Contract position: Leading medical device company is seeking a Quality Manager in Aliso Viejo, CA. The Quality Manager will be responsible for ensuring that the Quality Management System is compliant with US and International regulations and standards. Qualified candidates will have a BS degree in engineering or technical discipline and 4-6 years years of experience in medical device or pharmaceutical industries and knowledge of quality standards and regulations. Excellent long term opportunity. Responsibilities for the Quality Manager
Requirements for the Quality Manager
- Responsible for ensuring that Quality Management System (QMS) is compliant with required regulations
- Supports audits and inspections with FDA and international regulatory bodies and develops responses to corrective actions.
- Manages supplier quality activities including qualification and auditing.
- BS degree in engineering or related required.
- 4-6 years of experience in medical device or pharmaceutical industry
- Excellent working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, MDD, CMDR, MHLW Ministerial Ordinances and Brazilian requirements highly preferred
- Certified Manager of Quality, Quality Engineer and/or Quality Auditor preferred.
- Excellent interpersonal skills to interact with all levels of the company
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.