Quality Systems Program Mgr - Exempt

Job Title: Quality Systems Program Manager
Client: Medical Device Manufacturing Company
Duration: 7 months contract with possible extension
Location: Northridge CA 91325
Shift: 1st Shift

Job Description:
Experienced project manager in the medical device industry responsible for inspection readiness and QMS projects at Diabetes. Strong knowledge of regulatory requirements and standards including 21CFR820 and ISO 13485:2016.

Must Have:

• 15 years of experience in the medical device industry
• Bachelors Degree in Engineering
• Experience with Project Management 21CFR820 FDA ISO 13485 QMS

Nice to Have:

• Masters Degree
• Project Management certificates

HMs Top Needs:

• Medical Device industry experience (15 years)
• QMS Inspection Readiness
• Project Management

Responsibilities:

• Oversee development and maintenance of quality programs systems processes and procedures to ensure compliance with policies and standards.
• Interpret policies regulations and guidelines to assure compliance.
• Lead inspection readiness program coordinate audit and inspection resolutions and liaise with auditing groups and inspectors.
• Prepare reports and documentation such as Corrective and Preventative Actions for stakeholders.

Organizational Impact:

• Provide input for establishing program objectives timelines milestones and budgets.

Innovation and Complexity:

• Solve complex problems requiring detailed information gathering and analysis.
• Modify program management processes to improve programs.

Communication and Influence:

• Lead meetings with internal and external customers and vendors and conduct briefings to higher management.
• Solve issues through information exchange and persuasion.

Required Knowledge and Experience:

• Practical knowledge in leading and managing processes and projects.
• Advanced knowledge and skills in a specific technical or professional discipline.
• Bachelors degree required; Masters degree preferred.
• At least 15 years of experience in the medical device industry including project management.