Job Information
Spartronics Quality & Regulatory Manager in Cleveland, Ohio
Spartronics
Description:
Spartronics is more than just a company. We have great facilities, a dedicated and talented team, tremendous capacity and capabilities, and longstanding customers who need us. Now, it's all about driving forward with a winning strategy that builds on our strengths to create growth for our - customers, shareholders and employees. As an Electronic Manufacturing Services provider, we strive to meet and exceed our mission to be the preferred provider of fail-safe electronics solutions that save lives and protect what matters the most.
At Spartronics, we're not just building products, we build products lives depend on. As an electronic manufacturing services (EMS) provider for the commercial aerospace, defense, medical device, life science, and industrial markets, we work to deliver products of the highest quality and reliability.
Our organization provides comprehensive contract manufacturing services, ranging from printed circuit board assembly (PCBA) and subsystem integration to full-box build (high-level assemblies). Additional services include engineering support such as manufacturing testing, supply chain management, sustaining engineering, and a suite of aftermarket services to support the full OEM product lifecycle. With over $500 million in revenue, approximately 1,700 dedicated employees, and manufacturing resources strategically located worldwide, our manufacturing network spans the United States and Vietnam. To learn more about our sites, please visit .
Why Join Us:
When you become a part of Spartronics, you're joining a team of dedicated and talented, individuals who share a common goal - to win as one. We value talent, innovation, and a hunger for growth. Here, you'll have the opportunity to work with industry leaders in Aerospace & Defense, Medical & Life Science, and Industrial markets where our customers put full trust in us to deliver the most complex, highly regulated products that have to work the first time, every time.
Position: Quality & Regulatory Manager
On-Site Position: Strongsville, OH
Summary:
Manage the Quality Assurance, Regulatory, Compliance and Documentation Control functions to ensure that all processes and procedures associated with producing a quality product are complied with consistently. Primary interface with customer quality assurance representatives and quality system auditors. Champions quality improvement activities throughout the facility.
What a Day Looks Like:
Management Representative for Quality Management System.
Oversee and manage compliance of regulations that pertain to Design and Manufacturing of medical devices (FDA, ISO 13485, MDSAP, RoHS.) Stay current with new and changing regulations.
Provide guidance and interpretation for additional regulations such as IEC 62304, ISO 14971 as needed.
Provide Quality support to manufacturing, engineering, and support operations through the administration, collection, analysis of data, and the industry standards associated with each product line.
Ensure QMS support system, including IT infrastructure, tools, software and systems are compliant with industry regulations and standard practices.
Manage and lead FDA, ISO, Customer, Safety Agencies, and other third party audits.
Manage internal audit and layered process audit programs.
CAPA, advisory notice and complaint management.
Oversight of Validation, Change Control, and Temporary Deviation activity.
Manage weekly/monthly quality metrics.
Manage CAT/PPT meetings.
Prepare and lead Quarterly Management Reviews.
Oversees Quality related training to appropriate personnel.
Manage and develop Qu