Director of Quality
- Posted: over a month ago
- $105,000 to $150,000 Yearly
- Benefits: medical, vision, 401k, dental, life insurance,
Description for Director of Quality:
Experienced director responsible for managing all processes and deliverables in 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 organizations.
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 Director of Quality 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.
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.
- 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)
- 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
- Design organization that is resilient and sustainable that can withstand reasonable turnover
- Hold group events that build genuine and fun relationships
- Coach and Develop Supervisors/Leads in functional areas
- 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
Required Knowledge, Skills and Abilities for Quality Engineer 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
- 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.
This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.
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.
Poly-Med is the leading developer of bioresorbable polymers and fibers. We help innovative medical device companies focused on improving patient outcomes. Poly-Med designs, develops and manufactures superior materials to get customer products to market in the most efficient manner with the greatest improvement to quality of life. Located in Anderson, South Carolina, Poly-Med, Inc. has been recognized as a leader in the industry for over 20 years. Poly-Med continues to grow in a multitude of medical device modalities. Our novel materials are key in actively enabling products ranging from vascular stents, hernia meshes, dental delivery systems, dental hygiene, and a variety of wound closure applications in the worldwide medical device market.
For additional information, visit our website at www.poly-med.com.
We employ a widely diverse team comprised of experts from material science, chemical engineering, mechanical engineering, bioengineering, biology, business marketing, and project management to create a work environment focused on solving tough medically related problems. Our team is energetic, resourceful, and, above all, collaborative. We are searching for like-minded talent to build on our success and continue our quest to improve patient outcomes through novel polymeric and drug delivery systems.
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