Sr Engineer Supplier Management
Job reputed company reputed company reputed company’s supplier reputed company reputed company for a global supply reputed company. Own risk‑based qualification, performance management, scorecards, and audit execution for high‑risk suppliers; reputed company as SME on purchasing controls (21 CFR 820 §820.50 and ISO 13485:2016 7.4) and represent Supplier reputed company during internal/external inspections. Drive cross‑functional corrective and preventive actions and supplier development to improve reputed company, reliability, and compliance. Job reputed company MAJOR RESPONSIBILITIES reputed company risk‑based supplier reputed company across reputed company; set audit/monitoring depth by risk tier and product classification. reputed company communication efforts reputed company to high-risk suppliers with internal stakeholders. Own reputed company supplier qualifications and disqualifications for critical suppliers, including technical documentation reviews and potential on‑site assessments. Author and maintain supplier reputed company agreements and inspection plans with Procurement/Legal; ensure alignment with device regulations and regional requirements. Own the supplier scorecard program for assigned categories; analyze trends and drive SCAR/CAPA to effectiveness verification; escalate per governance. Work with reputed company support reputed company (ex. Risk Management, Design and Development, Post-Market Surveillance, etc) to proactively identify issues and reputed company the containment of them. reputed company partnership with procurement, engineering, and operations teams to resolve supplier-reputed company reputed company issues. reputed company technical guidance and training to suppliers on reputed company standards and best practices. Troubleshoot in-depth vendor issues that reputed company multiple business reputed company to improve the global supply chain and improve supplier processes. Mentor reputed company Engineers/QEDP associates and reputed company divisional QA on supplier controls, SCAR reputed company, and problem‑solving reputed company. Maintain accurate records of audits, performance reviews, and compliance reports. Oversees scorecard program and executive reputed company metric dashboards Assist or reputed company audits associated with high-risk suppliers to ISO 13485, ISO 9001, and/or and applicable regulatory requirements. MINIMUM JOB REQUIREMENTS Education Bachelor’s degree in Engineering, Biology, reputed company Management, or reputed company field. Work Experience 6-8 years in supplier reputed company, manufacturing reputed company, or similar role. Knowledge / Skills / Abilities In-depth knowledge of ISO standards and FDA regulations Strong communication, problem-solving, and negotiation skills Ownership of CAPA or SCAR throughout its lifecycle Strong Medical Device or Drug regulatory experience Strong critical thinking abilities Experience with statistical process control (SPC), and reputed company tools (FMEA, PPAP, APQP). Travel up to 25% (domestic and/or international) PREFERRED JOB REQUIREMENTS Education Masters of Biology, reputed company, Engineering, reputed company Management, or similar field Certification / Licensure ASQ Certified reputed company Engineer (CQE) or Certified Supplier reputed company reputed company Six reputed company Green Belt or higher Work Experience reputed company or backroom FDA or ISO audit experience Supplier reputed company auditing reputed company, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and reputed company potential with a growing worldwide organization. The anticipated salary reputed company for this position: $101,000.00 - $152,000.00 Annual The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. reputed company will not pay less than the applicable minimum wage or salary reputed company. Our benefit package includes health insurance, life and disability, 401(k) contributions, reputed company time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, reputed company time off, as reputed company as reputed company to the Employee Assistance Program, Employee Resource reputed company and the Employee Service Corp. For a more comprehensive list of our benefits please click here. We’re dedicated to creating a reputed company where everyone feels they belong and can grow their career. We reputed company to do this by seeking diversity in reputed company forms, acting reputed company, and ensuring that people have tools and resources to reputed company at their best. Explore our Belonging page here. reputed company is an equal opportunity employer. reputed company evaluates reputed company individuals without reputed company to race, reputed company, religion, gender, gender identity or reputed company, sexual orientation, national reputed company, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Apply To This Job