"Alerted.org

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.

Reporting directly to the Manager of Document & Data Management, the Quality Specialist of Document Management is a vital role within embecta, ensuring the efficient management and compliance of documentation processes that support the development, manufacturing, and distribution of life-enhancing medical devices.

This position is responsible for overseeing document control systems, maintaining regulatory compliance, and driving process improvements across embecta’s global operations. As an integral part of the Quality Systems team, the Quality Specialist ensures the accuracy, accessibility, and security of documentation critical to regulatory success, operational excellence, and product quality.

We prefer this position sit in our Parsippany office 2 days a week, but we are open to U.S. remote for the right person.

The Quality Specialist of Document Management is responsible for the following activities:

+ Administer and maintain embecta’s electronic Document Management System (SAP), ensuring documentation integrity, accessibility, and compliance with regulatory requirements.

+ Oversee the creation, review, approval, and distribution of controlled documents, including policies, procedures, work instructions, and quality manuals.

+ Perform overall document control of engineering design submittals and process reviews.

+ Ensure timely updates to documentation in response to regulatory changes, internal audits, or process improvements.

+ Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable standards.

+ Support regulatory audits and inspections by providing controlled documents and demonstrating robust documentation processes.

+ Provide guidance to stakeholders on proper documentation practices and regulatory expectations.

+ Identify and implement improvements to documentation systems and workflows to enhance efficiency and compliance.

+ Collaborate with Quality, Manufacturing, Marketing, Medical Affairs, R&D, and Regulatory Affairs teams to ensure alignment with documentation needs and organizational objectives.

+ Communicates with document originators and engineering personnel to resolve discrepancies and compile required changes to documents.

+ Assist with periodic reviews that include reviewing documentation practices and systems to ensure continued compliance and effectiveness.

+ Coordinate corrective actions to address nonconformances identified during audits.

Basic Requirements:

+ 5+ years of document control and change management experience in Medical Device or Pharmaceutical.

+ Bachelor’s Degree required.

+ Knowledge of 21CFR820/210/211/11, ISO 13485 and other applicable regulations.

+ Proficient knowledge of Document Control and Change Management.

+ Experience in systems such as SAP, Windchill or any other PLM system.

+ Full proficiency in Microsoft Office.

Preferred Requirements:

+ Excellent communication, problem solving, organizational and interpersonal skills are essential.

+ Self-motivated and directed.

+ Demonstrated ability to work in teams to obtain results is required.

+ Effective skills in analytical thinking and problem solving required.

_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._

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.