embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit  embecta.com  or follow our social channels on  LinkedIn ,  Facebook ,  Instagram  and X (http://twitter.com/embecta) .  **Why join us?** A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees. The Quality Compliance Auditor is a critical role within embecta, a global leader in medical device manufacturing. This position ensures that all quality systems and operations comply with internal standards and regulatory requirements, including FDA and ISO standards. The Quality Compliance Auditor plays a strategic role in maintaining embecta’s reputation for excellence by implementing, monitoring, and improving compliance processes. This position is instrumental in fostering a culture of continuous improvement while driving adherence to quality and regulatory expectations across the organization. This role will be hybrid 2 days in our Parsippany, NJ office **Responsibilities:** + Monitor the Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, ISO 14971, ISO 9001, MDSAP, EU MDR, and other applicable standards and regulations. + Conduct internal audits as required by the audit schedule. + Track and follow up for completion of nonconformance responses and action plans. + Support external regulatory inspections and Notified Body audits. + Monitor and report on key compliance metrics, identifying trends and areas for improvement. + Support that risks are identified, assessed, and mitigated effectively. + Support the organization’s documentation, including quality manuals, policies, and procedures, reflects current regulatory requirements and industry best practices. + Stay up-to-date with regulatory changes and industry trends, proactively updating processes and guiding teams to maintain compliance. **Basic Requirements:** + Bachelor’s degree in engineering, Life Sciences, or a related technical field. + 3+ years of experience in quality compliance or a related role within the Medical Device or Pharmaceutical manufacturing industry. + In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, ISO 9001, MDSAP, EU MDR, and other applicable standards and regulations. + Proven experience in conducting audits and managing regulatory inspections, including direct interaction with regulatory authorities. + Successful completion of internal and external audits. + Exceptional analytical and organizational skills with a detail-oriented approach to compliance management. + Proficiency in electronic Quality Management Systems (eQMS) and other compliance-related tools. **Preferred Requirements:** + Excellent communication and leadership skills, with the ability to collaborate effectively across teams. + Certified with Lead Auditor Training by an accredited organization. (i.e., NSF, ASQ, AAMI, UL). + Certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or equivalent are highly desirable. + Working with process Subject matter Experts (SME), successful resolution of any nonconformances identified during audits. + Timely and effective resolution of CAPAs, with measurable improvements in compliance metrics. + Reduction in compliance risks through proactive monitoring and process enhancements. + Accurate and up-to-date documentation reflecting regulatory and organizational requirements. + Positive feedback from cross-functional teams regarding compliance support and guidance. + Employee participation and engagement in training programs, demonstrating increased awareness of compliance expectations. _Competitive base salary based on experience and qualifications: $101,000 - $[133,800(subject to variation depending on physical location)._ _Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate’s experience, qualifications, external market conditions, and internal equity considerations._ _Base pay is one component of the Total Rewards package at embecta, which also includes eligibility for_ _an annual bonus._ _Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page._ _\#L1-WH1_ _\#-Hybrid_ embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.