Quality Manager - 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

• Provide regular feedback for team members (i.e. immediately after observed behavior)

Decision Making

• Advocate for the company, not just area of ownership team; Make best decision for the company overall

Strategic Planning and Status Reporting

• Manage areas of ownership through strategic planning and leadership
• Responsible for dashboards for all ownership areas

Resiliency Planning

• Design organization that is resilient and sustainable that can withstand reasonable turnover

Model Leadership

• Hold group events that build genuine and fun relationships
• Coach and Develop Supervisors/Leads in functional areas

Human Resources

• Perform HR responsibilities according to company standards, policies, and core values.
• Responsible for Professional Development planning for direct reports
• Set performance goals, including 90-day goals and annual goals for direct reports
• Ensure adequate training and performance of personnel as to executing their responsibilities in functional area
• Perform other duties as assigned

Required Knowledge, Skills and Abilities for Quality Manager:

• Includes all characteristics from Manager
• Ability to manage difficult relationships and resolve interpersonal issues
• Expert tactician and problem-solver
• Expert writing and verbal communication
• Excellent collaboration skills and ability to problem solve within peer groups

Education/Experience Requirements

• Bachelor’s degree. Master’s degree or higher highly recommended. Additional degrees and/or certifications and designations may be required or preferred depending on Quality requirements
• At least 5 years’ managerial experience and 5 working in Quality or Regulatory Affairs.
• Typically has technical knowledge but does not typically use it on a day-to-day basis
• MS Degree or higher in applicable field of science or engineering with 5+ years of related experience and 2+ years of leadership experience is preferred.

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.

• Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.