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 21CFR820/210/211/11, 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. 
•  Supports the Regional embecta entities with any Quality System’s related support such as CAPA assistance, Audit support, procedural guidance, etc.

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.

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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.