- 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.
- 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.
- Minimum Education: Bachelor's degree in engineering or related field required.
- Minimum Experience: 5 years minimum of related experience in quality, design assurance and/or design & development.
- Special Skills: Collaborative, Task Driven, Team Player, MiniTab, Office Suite, problem solving techniques.
- Specialized Knowledge: Knowledge of ISO and FDA quality and system requirements, risk management, process validation. CAPA, Document Change Management, NCR, and Statistical Expertise required.
- Other: ASQ Certifications, optional.
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Quality Manager- Spiddal Galway - Integer Holdings Corporation
Description
By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers' success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
Accountabilities & Responsibilities:
Supervisory Duties
Education & Experience:
Knowledge & Skills:
U.S. Applicants: EOE/AA Disability/Veteran
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