Device Quality - QMS Lead, Combination Products
The Device Quality - QMS Lead, Combination Products has job responsibilities that include but are not limited to:
- Ensure compliance to cGMP, 21 CFR Part 4, BMS standards and other global health authority requirments for medical devices/combination products.
- Assist with periodic audits of device component suppliers, external design houses, service providers, and contract manufacturers and distribution centers
- Author or coordinate the writing of comprehensive quality system documents. Initiate, update, review, or assist in the drafting of the quality manual, policies, directives, standard operating procedures and work instructions.
- Ensure that new medical device/drug combination products follow the appropriate design control process consistent with health authority regulations/expectations.
- Ensure risk management is executed through Risk Management Plans, Risk Files, Hazard analyses, and risk analyses eg dFMEA, pFMEA, uFMEA etc. throughout the life cycle of the product.
- Provide consultation and training on combination products and medical devices to internal and cross-functional groups
- Lead Quality System improvement initiatives
- Support the device quality councils/mangement reviews by generating relevant data to be presented to management regarding the status of the Device QMS
- Participate in teams to generate, update or assist in the drafting of policies, procedures, and work instructions related to product quality metrics (eg, risk assessment for product quality complaints, product quality complaint surveillance thresholds, etc).
- Serve as SME for evaluating the impact and applicability of new device/combination product regulations via the PEARLprocess.
- The position requires a minimum of a Bachelor of Science degree. A life science degree is preferred, e.g., Pharmacy, Chemistry, Biology, Engineering.
- Direct Quality unit responsibility for the development and commercialization of medical device/drug or biologic combination products.
- Minimum of 8 years experience in medical device/drug combination product development and manufacturing role, in a Quality, Technical, or Regulatory position or a combination thereof.
- Direct experience in supporting commercial manufacturing sites and HQ groups through global health authority inspections.
- Expert in Quality System Regulation, Part 4, Combination Product Guidance and cGMP.
- Demonstrated experience leading and contributing through influence and working in cross functional teams to investigate and manage quality and compliance related issues.
- Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
- Knowledge in combination product design, development, and manufacturing, Quality Assurance, Validation, Technology Transfer, Supply Chain, Packaging, Surety, and Logistics.
- Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
- In-depth knowledge of quality systems principles and applications.
- Demonstrated ability to work independently and with groups of people/teams in a complex changing environment.
- Excellent oral and written communication skills.
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments.
- Ability to provide innovative, compliant ideas or alternatives that create value including seeking new information and external insights.
- Pragmatic in approach with demonstrated ability to make sound, risk-based decisions
- Mastery of Quality processes and regulations, e.g., GMP regulations. A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality and complaint investigations.
- A minimum of 2 years of CGMP/QSR auditing experience, preferably certified device auditor (e.g., ISO RAB, etc).
- In depth knowledge of product attributes as they relate to regulations..
- A minimum of 7-10 years of experience in Quality Operation
- Knowledge of effective styles of communication, change management, and leadership.
- Ability to analyze and solve complex problems.
- Ability to work independently and use initiative.
- Ability to prioritize work and rapidly change priorities when necessary.
- Ability to develop win/win solutions.
- Ability to effectively manage difficult people and situations