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Quality Systems Program Mgr

Northridge, CA 91325

Posted: 06/18/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 608843 Is job remote?: Yes Country: United States

Job Description

pay 80-90/h depending on experience

HM's Top Needs:

1. Medical Device industry experience (15+ years)

2. QMS, Inspection Readiness

3. Project Management

Experience project manager in the medical device industry, responsible for the inspection readiness program and QMS related projects at Diabetes.

Strong knowledge and experience dealing with regulatory requirements and standards including 21CFR820 and ISO 13485:2016.

Expected bachelor’s degree, preferable in engineering.

Master’s degree preferred. 

Years’ Experience Required: +15

Responsibilities may include the following and other duties may be assigned. Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

Leads inspection readiness program, coordinates resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

Organizational Impact: Provides input to establishing program objectives, timelines, milestones, and budgets.

Innovation and Complexity: Problems faced are difficult, and require detailed information gathering, analysis and investigation to understand the problem. Problems typically impact multiple workstreams, departments or specialties . Modifies programs management processes to improve program. Communication and Influence: Communicates and leads meetings with internal and external customers and vendors, conducts briefings to higher level management team. Solves issues through information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans. Direct involvement in daily tasks necessary for successful program execution. Not directly responsible for hire or fire decisions and people management. Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. 

Requires a Bacherlor degree, Master degree preferred.
Requires at least 15 years of experience in medical device industry, which needs to include project management. 
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About Northridge, CA

Ready to kickstart your career in Northridge, California? This bustling city in Los Angeles County is not just a hub for job opportunities but also offers a unique blend of urban and suburban living. Northridge boasts a vibrant arts scene with the Valley Performing Arts Center and The Soraya, inviting residents to enjoy world-class performances. With proximity to the stunning Santa Susana Mountains and the Pacific Ocean, outdoor enthusiasts can explore nature at Limekiln Canyon Park or take a leisurely stroll through the beautiful CSUN Botanic Garden. Indulge in the diverse and flavorful cuisine at local eateries while cheering on the CSUN Matadors or catching a game at the iconic Dodger Stadium nearby. Discover your next career move in Northridge and immerse yourself in a city that offers endless growth opportunities and an irresistible charm that's hard to resist. Explore our job listings now and take the first step towards a fulfilling career in this dynamic region.

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