HireTalent
Quality Systems Program Mgr - Exempt
HireTalent, Los Angeles, California, United States, 90079
Must Have:
15+ years of experience in the medical device industry
Bachelor's Degree in Engineering
Experience in Project Management, 21CFR820, FDA, ISO 13485, QMS, Medical Device industry standards
Nice to Have:
Master's Degree
Project Management certifications
Job Description:
Spotlight Call with Hiring Manager:
1/17 at 1pm CST
Do you have the skills to fill this role Read the complete details below, and make your application today. Phone conference ID: 305 820 283# Target Rate:
*** /hr Hiring Manager's Top Needs: Medical Device industry experience (15+ years) QMS, Inspection Readiness Project Management The candidate will be an experienced project manager in the medical device industry, responsible for inspection readiness programs and QMS-related projects, particularly in Diabetes. Strong knowledge of regulatory requirements and standards, including 21CFR820 and ISO 13485:2016, is essential. A bachelor's degree, preferably in engineering, is required, with a master's degree preferred. The position requires over 15 years of experience. The role is full-time, working 40 hours per week, with a preference for candidates located in Northridge, CA, though remote candidates will be considered. Responsibilities include: Overseeing the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external standards. Leading inspection readiness programs, coordinating audit and inspection findings resolution, and liaising with auditors and inspectors. Preparing reports and documentation such as CAPAs. Providing input on program objectives, timelines, milestones, and budgets. Addressing complex problems requiring detailed analysis, impacting multiple departments or workstreams. Communicating effectively with internal and external stakeholders, leading meetings, and influencing without direct authority. The role requires practical knowledge in managing processes, projects, and tactics within the medical device field, with advanced technical or professional expertise. A bachelor's degree is required, with a master's degree preferred, and at least 15 years of relevant experience, including project management in the medical device industry.
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1/17 at 1pm CST
Do you have the skills to fill this role Read the complete details below, and make your application today. Phone conference ID: 305 820 283# Target Rate:
*** /hr Hiring Manager's Top Needs: Medical Device industry experience (15+ years) QMS, Inspection Readiness Project Management The candidate will be an experienced project manager in the medical device industry, responsible for inspection readiness programs and QMS-related projects, particularly in Diabetes. Strong knowledge of regulatory requirements and standards, including 21CFR820 and ISO 13485:2016, is essential. A bachelor's degree, preferably in engineering, is required, with a master's degree preferred. The position requires over 15 years of experience. The role is full-time, working 40 hours per week, with a preference for candidates located in Northridge, CA, though remote candidates will be considered. Responsibilities include: Overseeing the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with internal policies and external standards. Leading inspection readiness programs, coordinating audit and inspection findings resolution, and liaising with auditors and inspectors. Preparing reports and documentation such as CAPAs. Providing input on program objectives, timelines, milestones, and budgets. Addressing complex problems requiring detailed analysis, impacting multiple departments or workstreams. Communicating effectively with internal and external stakeholders, leading meetings, and influencing without direct authority. The role requires practical knowledge in managing processes, projects, and tactics within the medical device field, with advanced technical or professional expertise. A bachelor's degree is required, with a master's degree preferred, and at least 15 years of relevant experience, including project management in the medical device industry.
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