embecta

Compensation

Full Description

Note: The job is a remote job and is open to candidates in USA. 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. The Quality Systems Specialist is responsible for supporting the development and improvement of the Global Quality Management System, maintaining compliance with regulations, and collaborating with various functions within the organization. Responsibilities • 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. • 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. Skills • 5+ years relevant experience in healthcare. • 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. • 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. Education Requirements • Bachelor’s Degree required. Benefits • Annual bonus • Medical • Dental • Vision • Retirement savings plans • Paid time off Company Overview • Embecta is a provider of diabetes healthcare services. It was founded in 2022, and is headquartered in Franklin Lakes, New Jersey, USA, with a workforce of 1001-5000 employees. Its website is https://www.embecta.com. Company H1B Sponsorship • embecta has a track record of offering H1B sponsorships, with 3 in 2022. Please note that this does not guarantee sponsorship for this specific role.