Permanent position: Multi billion dollar medical device manufacturing company in Northern California is currently in search for a Quality Assurance Program Manager. The Quality Core team member will be responsible for representing the quality function in all discussions and decisions on the core team. The Quality Program Manager should have a minimum of 5 years experience in Program Manager and Quality and an advanced Engineering degree. Responsibilities for the Program Manager
Requirements for the Program Manager
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Co-ordinates legal requests in support of government investigations or litigation's.
- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Partners with Subject Matter Experts to drive development of clear objectives. for education packages that improve competency.
- Guides the architecture, governance, and measurement of the program.
- Bachelors degree with 5+ years of experience in quality and/or program management or advanced degree with 3+ years of experience in quality and/or program management.
- Regulated industry experience (medical device, biotech and pharma)
- Proven ability to manage the activities of one or more small / medium scale projects or sections of projects.
- Practical project /program management experience
- Experience working in multiple functional disciplines e.g.: Design assurance, Quality engineering, Process Development, R&D, Clinical/ Regulatory ideally in Class III devices
- Demonstrates strong understanding of technical and business PDP requirements
- Industry leading comprehensive compensation package, 401K match, paid holidays and vacations.
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.