Quality Manager- Spiddal Galway - Integer Holdings Corporation

Description

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Quality Manager- Spiddal Galway

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:

• 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.

Education & Experience:

• 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.

Knowledge & Skills:

• 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.

U.S. Applicants: EOE/AA Disability/Veteran

About Us

Integer Holdings Corporation (NYSE:ITGR) is the largest medical device outsource (MDO) manufacturer in the world serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and power solution markets. The company provides innovative, high quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company's brands include Greatbatch Medical, Lake Region Medical and Electrochem. Additional information is available at .

Integer is committed to equal opportunity for all, without regard to race, color, religion, creed, national origin, ancestry, ethnicity, sex (including pregnancy and gender), age, physical or mental disability, citizenship, veteran or military status past, current, or prospective service in the uniformed services, genetic information, sexual orientation, gender identity, marital status, or any other characteristic protected under applicable legally recognized protected basis under federal, state or local law. Greatbatch Integer complies with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. Consistent with those legal requirements, Integer will make reasonable accommodations for qualified individuals with a known physical or mental limitations of otherwise qualified employees and applicants with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless the accommodation would impose an undue hardship on the operation of our business. If you are interested in applying for an employment opportunity and feel believe you need a reasonable accommodation pursuant to the ADA, please contact us at . All postings presume work will be performed entirely outside of Hawaii, California, Colorado, Maine, Connecticut, and Washington, and New York (where management is based outside of NY state)

To review the Integer U.S. Applicant Privacy Statement click here .