Job Information
Actalent Quality Systems Program Manager in Northridge, California
Description:
HM's Top Needs:
Medical Device industry experience 15 years
QMS Inspection Readiness
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 bachelors degree preferable in engineering.
masters degree preferred.
Years of experience Required: 15
Will the contractor be working 40 hours a week? If not weekly estimate? Yes
Work Location:
Do they need to be local to any MDT office and if so where? Preferred in Northridge CA
Does this person need to be on site? If so full time or part time? Preferred in Northridge CA but remote candidates would be considered.
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 Bachelors degree Master degree preferred.
Requires at least 15 years of experience in medical device industry which needs to include project management.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.