Integer Senior Manager, Quality Assurance in Brooklyn Park, Minnesota
At Integer, our vision and values are embedded in everything we do!
If you want to work for an organization that values customer focus, teamwork, respect, integrity, communication and innovation, apply now!
Adheres to Integer Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
Develops, maintains and improves the quality management system to ensure compliance to the FDA Quality System Regulation, international requirements such as ISO 13485, and ensures production of finished products meet quality requirements.
Develops and maintains auditing processes, procedures and activities to maintain compliance with quality standards and customer requirements.
Manages, directs and advises on the establishment of site documentation and procedures including document control and records required for traceability of products though out the business unit.
Leads and directs the site Quality function to assure successful new product design transfer and post-market surveillance by collaborating with the Operations, R&D, NPI, Commercial, and Regulatory functions.
Directs the continued review of quality activities and the creation of new or revised processes to ensure quality improvements reduce costs and enhance efficiency.
Aligns Quality function resources with site productivity efforts while ensuring all product quality and quality system compliance requirements are met.
Provides ongoing communications and supports Plant Management toward attainment of Business Unit and Integer Financial and Operational Objectives.
Creates a strong and accountable Quality team through the coaching and leading of supervisory staff, and the hiring and planned development of team members.
Maintains effective working relationships with internal and external customers and vendors to establish quality standards prior to initial production, and to resolve technical and business related quality issues post-production.
Establishes and manages departmental strategic, tactical plans, and metrics. Additionally this function establishes and manages budget to support Quality function and Category team requirements.
Promotes interdepartmental coordination and communication to ensure successful execution of Operations Quality Strategy.
Acts as site Management Representative.
Performs other functions as required.
Bachelor’s degree in Engineering, Math or Statistics. Master’s degree preferred.
10-12 years of experience in a technical function with 5 years in managerial experience.
Prior experience as a Quality Management Representative preferred.
Experience with ISO, GMP, and related quality systems.
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 https://integer.net .
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
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