Quality & Regulatory Manager at Spartronics LLC

Strongsville, Ohio, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Mar, 26

Salary

0.0

Posted On

18 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Documentation Control, Medical Device Regulations, Quality Improvement, Data Analysis, Internal Audits, CAPA Management, Validation Oversight, Change Control, Training Skills, Statistical Techniques, Communication Skills, IT Infrastructure Compliance, Customer Interaction, Team Management

Industry

electrical;Appliances;and Electronics Manufacturing

Description

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 https://www.spartronics.com/locations. 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 Quality department employees’ job performance. Requirements Bachelor’s degree in engineering or relevant field. 5 years of experience in a relevant Quality/Regulatory position in the medical device industry or equivalent experience. Knowledgeable in medical device laws and regulations (ISO 13485 and FDA CFR). Good working knowledge of quality statistical techniques. Expertise in software programs such as Word, Excel, PowerPoint. Strong communication and training skills. All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee. We can not provide sponsorship Our Commitment: At Spartronics, we're dedicated to fostering an inclusive, diverse, and equitable workplace. We believe that diverse perspectives drive innovation, and we welcome candidates of all backgrounds to apply. Our culture at Spartronics values accountability, unity, respect, and transparency. These winning values are the lifeblood of our business. We embrace diversity through people who believe in these values. Embracing our employees’ differences enables us to be a stronger team. Join Our Journey: If you're ready to be a part of something extraordinary, challenge the status quo, and shape the future, then we want to hear from you. Together, we'll continue to win, while we build products lives depend on. Our Benefits: Full range of medical, dental, and vision benefits. Medical plan options include 1 PPO plan and 2 High Deductible Health Plans (HDHP) with a Health Savings Account (HSA). By completing an annual Wellness Exam, you will save $ on your PPO plan. Or, on the HDHP, we contribute $750 (single) or $1,500 (family) to an HSA. Flexible Savings Accounts for Medical, Dependent Care, and Limited Purpose (dental and vision only) PTO and Holiday Pay Company-paid life insurance and disability at 1 times your annual salary at no cost to you, with options to increase coverage amounts 401k with a company match of 50% to every dollar up to 6% Accident, Critical Illness, Hospital Indemnity, and Legal Insurance optional plans Employee Assistance Program Tuition Reimbursement Opportunities to grow and excel in the Electronics Manufacturing industry at a company that values promotions and learning from within. Every day is different, challenging, and rewarding. How to Apply: If this sounds like the perfect opportunity for you, please apply with your resume and a cover letter outlining your qualifications and why you're excited about joining Spartronics. Spartronics is an equal opportunity Employer/Veteran/Disabled 41 CFR 60-1.4. We comply with federal Affirmative Action guidelines in all employment opportunities for qualified employees and applicants. We encourage applications from candidates of all backgrounds and experiences.

Responsibilities

Manage the Quality Assurance, Regulatory, Compliance, and Documentation Control functions to ensure compliance with processes and procedures for producing quality products. Act as the primary interface with customer quality assurance representatives and lead quality improvement activities throughout the facility.