Quality Systems Program Manager

Three Point Solutions

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
Bachelor's Degree in Engineering
Experience with Project Management, 21CFR820, FDA, ISO 13485, QMS

Nice to Have:

Master's Degree
Project Management certificates

HM's 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.
Bachelor's degree required; Master's degree preferred.
At least 15 years of experience in the medical device industry, including project management.

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Vacancy posted 4 days ago

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