Manager, Quality
Integer Holdings Corporation
Summary
The primary purpose of this position is to assume responsibility for the planning and management of a Design Center Quality Team, which includes Quality Systems and Design Assurance. This position will manage a team to meet site/organizational goals and customer expectations. Responsible for providing metrics and leadership for implementing and achieving Quality objectives.
Job description
Accountabilities & Responsibilities
- Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Maintains safe and ethical business practices and adheres to Integer's Quality Policy.
- Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to design transfer, and to resolve technical and business-related quality issues post-commercialization.
- Establishes and manages departmental goals, tactical plans, and metrics.
- Promotes interdepartmental coordination and communication to ensure successful execution of the Integer Quality Strategy.
- Performs other duties as required.
Design Assurance
- Manages and sets priorities of the Design Assurance Engineer(s) and Quality Technician(s).
- Maintains and improves the design control and risk management processes to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and to ensure the design of finished products and/or components that meet quality requirements.
- Leads the Design Assurance function to assure successful new product design transfer by collaborating with the Research and Development and Operations functions.
- Ensures the following activities occur in accordance with current procedures: test method development & validation, finished products verification, component verification, validation as part of transfers to production and design reviews.
- Responsible for the continued review of design assurance activities and processes to ensure effective design controls, risk containment, cost reduction and enhance efficiency.
Quality Systems
- Manages and sets priorities of the Quality System Specialists
- Responsibilities over CAPA, Document Control, Internal Audit, Management Review, and Training
- Promotes and maintains alignment of Site QMS Documents with QMS Enterprise Policies.
- Participates and/or leads project teams for the implementation of enterprise and site Quality objectives.
- Organizes and provides training and mentoring for quality improvements to enhance Associate skills, increase awareness, and improve productivity.
Supervisory Duties
- Interviews, hires, and establishes training plans for direct reports. Provides leadership regarding development of individuals' goals as well as providing mentoring of the group.
- Manages team in a manner that fosters a self-directed and collaborative team approach.
- Facilitates communication, coordination and conflict resolution within and among work groups.
Requirements
- Bachelor's degree in engineering or related field required
- 5 years minimum of related experience in quality, design assurance and/or design & development
- Collaborative, Task Driven, Team Player
- MiniTab, Office Suite, problem solving techniques
- Knowledge of ISO and FDA quality and system requirements, risk management, process validation
- CAPA, Document Change Management, NCR, and Statistical Expertise required
- ASQ Certifications, optional
Benefits
- Medical, Dental & Vision
- Disability Insurance
- Life Insurance
- Adoption Benefits
- Parental Leave
- Supplemental Life Insurance
- Critical Illness Insurance
- Hospital Indemnity Insurance
- Accident Insurance
- 401(k) Matching
- Paid Time Off
- Company Holidays
Company overview
Integer Holdings Corporation (NYSE: ITGR) is one of the world's largest medical device contract development and manufacturing organizations (CDMO), serving as a strategic partner to leading medical device companies and OEMs globally. With an 80-year legacy of innovation, the company specializes in advanced medical device outsourcing across cardiac rhythm management, neuromodulation, and cardio and vascular markets. Integer operates through its two primary brands, Greatbatch Medical® and Lake Region Medical®, offering comprehensive solutions from product design and development to finished device manufacturing. The company's extensive product portfolio includes catheters, guidewires, delivery systems, implantable batteries, capacitors, and Class III medical devices, serving over 15 medical markets. With manufacturing facilities spanning four continents and more than 2.5 million square feet of production space, Integer provides vertically integrated supply chain solutions that help medical device companies accelerate time-to-market while maintaining uncompromising quality and regulatory compliance standards.