Quality Systems Specialist

Quality Systems Specialist page is loaded## Quality Systems Specialist locations:
USA NJ - Parsippanytime type:
Full time posted on:
Posted Todayjob requisition :
Rembecta 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, visitor follow our social channels on,,and.

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.

As directed by the Senior Manager, Global Quality Systems, the Quality Systems Specialist is accountable for support in the continued development, improvement, and expansion of the embecta Global Quality Management System as well as maintaining compliance with regulations, standards, and Global requirements. This position provides collaborative support to quality system leadership and may work with other functions within the organization including Operations, Quality Engineering, Quality Operations, R&D, Procurement, Marketing, Regulatory and Medical in addition to Global functions, regulatory agencies, and suppliers.

This role is the Global Process Owner for the CAPA System.
** We prefer this position sit in our Parsippany, NJ office hybrid 2 days a week, but we are open to remote in the U.S. for the right person.
** Primary Responsibilities will include the following:
* Oversight of the Quality Improvement Processes.  This will include working with the plants regarding Nonconforming Product, Global Holds, and the CAPA system.
* Applies consistent and extensive application of technical principles, theories, concepts and quality sciences, tools, and systems with measurable / confirmed results.
* Investigates product and process issues, helping to determine root cause, and establishing effective corrective action.
* Provides training for product development teams, continuous improvement teams, and manufacturing plants on best practices. This is done formally and informally.
* Owns the Global CAPA Review Board. Prepares the data and leads the monthly meetings ensuring the Global CAPA Systems is adequately maintained.
* Owns the Global Quality Process Nonconformance process.
* Provides Global support to the eCAPA System by liaising between sites and IT when issues within the system are identified. Provides support on resolving systems requirements that need a higher System access level.
* Represents the Business level for any changes associated to the eCAPA System. Supports Validations and Reviews User Requirements.
** Basic Requirements:
*** 5+ years relevant experience in healthcare.
* Bachelor’s Degree required.
* Knowledge of 21

CFR
820/210/211/11, ISO 13485 and other applicable regulations.
* Understanding of continuous improvement methodologies including Lean, Six Sigma, SPC, etc.
* Ability to support internal / external audits.
* Experience with root cause analysis using formal tools.
* Full proficiency in Microsoft Office.
*** Preferred Requirements:
**** Certified Quality Engineer and/or Certified Quality Auditor preferred.
* 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.
* Supports External Audits as an Subject Matter Expert (SME) and presenting evidence and processes to the auditor(s) in a professional manner and ensuring embecta Quality System is always well represented.
*…