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embecta
Supplier Quality Specialist
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What they do
A Quality Assurance Auditor regularly evaluates the quality control systems in place and verifies compliance with quality and safety standards.
$72,709 / year median in the U.S.
-4% projected decline
Job Description
embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. Driven by innovation, purpose, and a commitment to improving lives, we are expanding our portfolio of solutions to serve even more patients, healthcare providers, and communities around the world. Why embecta? Imagine the long legacy and global scale of an industry leader combined with the agility, speed, and entrepreneurial energy of a startup—that's embecta. We are evolving from a company with more than 100 years of experience in diabetes care into a broader medical supplies organization, helping more than 30 million people worldwide live their best lives through innovative solutions, partnerships, and the strength of our global team. At embecta, you are empowered to take ownership, bring your authentic self to work, and accelerate your career alongside inspiring leaders. The Supplier Quality Specialist plays a critical role in maintaining and enhancing the quality processes that ensure suppliers, contract manufacturers, distributors, 3PLs, and external partners meet embecta quality, regulatory, and supply chain compliance expectations. This is an exciting opportunity for a professional who enjoys working across functions, solving complex compliance challenges, improving processes, and driving operational excellence in a highly regulated medica device environment . This role can be remote if not local to
Parsippany, NJ What You'll Be Doing:
- Execute assigned Supplier & Distribution Management quality processes in accordance with approved procedures and regulatory expectations.
- Compile, review, and maintain quality records, reports, metrics, and supporting documentation.
- Coordinate cross-functional follow-up to ensure required actions, evidence, and decisions are documented and completed on time.
- Support investigations, trend reviews, audit preparation, inspection readiness, and management review inputs as applicable.
- Identify process gaps, documentation issues, data quality concerns, and opportunities to improve compliance and standardization.
- Support training, procedure updates, data analysis, and communication of quality process requirements.
- Maintain accurate, complete, and inspection-ready records in applicable quality systems.
What We're Looking For:
Required Qualifications:
- Relevant bachelor's degree required, such as Life Sciences, Engineering, Quality, Regulatory, Business, or a related discipline.
- 3-5+ years of relevant experience in quality, compliance, quality systems, post-market surveillance, supplier quality, distribution quality, or a related regulated-industry function.
- Experience maintaining quality records, supporting audits or inspections, managing follow-up actions, and working within controlled quality system processes.
- Working knowledge of medical device quality requirements, Good Documentation Practices, CAPA, change control, training, and document control expectations.
- Working knowledge of supplier controls in the life sciences industry.
- Strong analytical thinking, technical judgment, risk-based decision making, and structured problem-solving capability.
- Excellent written and verbal communication skills with the ability to translate complex quality topics into clear business language.
- Ability to collaborate effectively across functions, regions, sites, suppliers, and external partners.
- Strong organizational skills with the ability to manage priorities, maintain accurate records, and deliver commitments in a regulated environment.
- Commitment to data integrity, Good Documentation Practices, inspection readiness, continuous improvement, and patient/customer focus.
Preferred Qualifications:
- Skill in applying supplier audit methods, quality agreements, supplier scorecards, SCAR/CAPA, PPAP where applicable, FMEA, SPC, MSA, SAP, PLM/eQMS, and distribution risk management to solve quality and compliance problems.
Benefits
- Paid Time Off (PTO)
- Other Retirement and Savings
- Health Insurance
- Dental Insurance