What are the responsibilities and job description for the Quality Manager position at Poly-Med, Inc.?
Description for Quality Manager :
Experienced manager responsible for managing all processes and deliverables multiple designated functional areas. Passes on the company vision and develops the execution strategy. Responsible for management level succession planning. Develops the execution plan and holds others accountable for achieving it. Develops KOIs that best reflect the performance and risks of each operational area. A blend of expertise in Class II and III devices including combination products or pharmaceutical applications is desired. Implementation of streamline approach to 211 Part 4 is desired, as well as applicable knowledge in best practices for process validation and 21 CFR part 11 implementation across a manufacturing organization.
Responsible for general planning and guidance that spans several functional areas. Balances all functional area priorities with overall strategies and direction of the company when planning and making decisions. Must resolve conflicts between functional areas to determine the most effective allocation of company resources. Excellent knowledge of and experience with QSR / GMP principles, reporting, device tracking, post market surveillance, and compliance actions such as recalls, safety alerts, technical bulletins, Form 483s and Warning Letter response.
The Quality Manager is responsible for managing all quality processes and deliverables. Supervises all quality staff. Relies on significant experience and judgment to plan and accomplish goals; shares best practices with all quality staff.
Scope :
Direct reports may include all levels of Quality. Interaction is with all levels of the organization.
Directly accountable to an Assistant Director, Director, or the President. Manages and supervises individual contributors.
Responsibilities :
- Oversees all Quality Systems as required to ensure ISO 13485 : 2003 Compliance for Poly-Med, Inc.
- Serves as the Management Representative for Quality department and for audit Participated DDP representation.
- Serves as the interim lead internal auditor.
- Review, approval, and compliance with all Quality Agreements.
- Manages quality metrics, internal audit program, and performs validation review and approval.
- Supports compliance to Good Documentation Practices as specified within the Quality System requirements for Poly-Med, Inc.
- Manages and coordinates all levels of the Quality Job Family to ensure compliance to ISO 13485 : 2003 for Poly-Med, Inc.
- Actively contributes to company management as a member of the Poly-Med executive leadership team.
- Collaborates with the executive team to manage quarterly leadership team meetings and key strategic projects.
- Regularly performs annual reviews for group and provide input to salary and bonus decisions.
- Responsible for developing and implementing quality assurance, quality systems management, and data management for CMO with the ability to tailor a QMS to the intended use / risk of the program
- Oversite of analytical requirements for product release.
- Responsible for designated Operational Areas
- Passes on the vision & develops execution strategy
- Understands alignment of their Area to the entire business and developing the strategy for their area to accomplish it
- General planning and guidance that spans several functional areas
- Balance department priorities with overall strategies and direction of the company when deciding the best approach
- Experienced manager that typically has technical knowledge but does not typically use it on a day-to-day basis
- Must resolve conflicts between functional areas to determine the most effective allocation of company resources
- Delegates day-to-day control to the functional manager
- Developing the execution plan and holding others accountable for achieving it
- Develop KPIs that best reflect the performance and risks of each operational area
- Overall accountability for multiple functional areas
- Responsible for management level succession planning
- Excellent interpersonal, writing, negotiation and time management skills.
Build a team
Decision Making
Strategic Planning and Status Reporting
Resiliency Planning
Model Leadership
Human Resources
Required Knowledge, Skills and Abilities for Quality Manager :
Education / Experience Requirements
Working Conditions at Poly-Med, Inc. :
At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.
Physical Requirements :
Employees are regularly required to talk and hear and are frequently required to sit and / or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and / or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.
Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.