Senior Quality Program Manager - ISO 13485 and FDA 21 CFR Part 820 for medical devices

Latham, NY, US • Posted 2 days ago • Updated 2 days ago

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On-site

$70 - $80/hr

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FDA 21 CFR Part 820 for medical device

Summary

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Program Management: Manages multi-site or medium/high complex programs over 2 3 years or financial impact of ? 10M. Innovates and elevates program and portfolio capabilities.
Strategic Leadership: Provides strategy and direction for major functional areas through assessment of intangible variables and identification of fundamental issues.
Risk Management: Encourages balanced risk-taking and mitigates risks to maintain program health. Familiarity with risk management standards such as ISO 14971.
Quality Compliance: Utilizes quality principles (QMS, CAPA, Nonconformance, Calibration, PM, Process and Production Controls, Warehousing, etc.) within project management.
Stakeholder Engagement: Interacts internally and externally with senior-level management; negotiates extremely critical matters including influencing policymaking.
Methodology & Coaching: Expertise in applying PM standards (PMI, PMBoK, SAFe) and coaching others in project/program management processes.
Operational Execution: Uses detailed knowledge of company operations to promote innovative concepts and develop resolutions to critical issues. On-site presence required.

Minimum Requirements
Education: Bachelor s or Master s degree in life sciences, business administration, or engineering.
Experience: 5 10 years of relevant working experience, including all aspects of project development and execution. 5+ years of program management experience with a demonstrated record of success.
Certification: Philips Project Management Practitioner/Expert/Master or equivalent (PMI, PMBoK, SAFe).
Compliance Knowledge: Knowledge of ISO 13485 and FDA 21 CFR Part 820 for medical devices; comprehensive training in Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Preferred Qualifications
Experience: Experience working in programs specifically supporting the program manager in program management activities.
Expertise: Known authority on process-oriented skills with consistent application.
Preferred Skills

Project/Program Management (PMI, PMBoK, SAFe)
Quality Management Systems (QMS)
CAPA Processes
ISO 13485 & FDA 21 CFR Part 820
ISO 14971 Risk Management
Strategic Planning & Policy Influencing
Negotiation & Senior Stakeholder Management
Innovative Problem Solving

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Position Id: PHIAJP00003623
Posted 2 days ago

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Latham, New York

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Education: Bachelor s or Master s degree in life sciences, business administration, or engineering. Experience: 5 10 years of relevant working experience, including all aspects of project development and execution. 5+ years of program management experience with a demonstrated record of success. Certification: Project Management Practitioner/Expert/Master or equivalent (PMI, PMBoK, SAFe). Compliance Knowledge: Knowledge of ISO 13485 and FDA 21 CFR Part 820 for medical devices; comprehensive tr

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Senior Quality Program Manager - ISO 13485 and FDA 21 CFR Part 820 for medical devices

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