Job Description
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.
As directed by the Director Supply Chain quality, the the Supplier Quality Analyst - NPI will lead the on boarding of new products, and or product market extension activities into the embecta systems. This position will be critical in the management of change controls, coordination and management of supplier risk classification, supplier audits, and the on time delivery of Supplier Quality Agreements. This position will work cross functionally across embecta teams to ensure all requirements to the embecta QMS are ready on time to delivery timeline launches and market extensions. This position will also engage in continuous improvement projects to streamline embecta processes while ensuring all compliance requirements are met and documented.
The scope of the role encompasses, but is not limited to
·* *Coordination and management of Supplier Risk Classification documents
·* *Support the timely scheduling and completion of Supplier Audits
·* *Participate in and lead supplier audits globally
·* *Confirming all activities to add suppliers to the ASL are completed prior to product launch
·* *Driving the change control process and leading the cross functional team to provide deliverables on time
·* *Support SKU activation for new products and ensuring all quality systems are tested prior to launch.
- Lead Lean initiatives to streamline embecta processes for supplier onboarding and management to drive improved performance.
RESPONSIBILITIES:
Lead lean initiatives to identify and implement improvements to the vendor on boarding process, related to new products, suppliers, change control, management and other related quality controls.
Responsible for the governance of the change management process to ensure accuracy, efficiency and compliance. Work with Project leaders and team members to determine change implementation strategies and to identify/collect controlled documents and SAP master data objects that will be impacted by proposed changes. Ensures that change packages are complete for release implementation according to ECR strategy and system requirements.
Participate in remote and on site supplier vendor audits to support the on boarding to our Approved Supplier List.
EXPERIENCE & EDUCATION:
EXPERIENCE:
- Experience in good documentation practices
- Understanding of life sciences quality system management
- Experience with SAP ERP systems
- Knowledge of life science change control procedures and practices
COMPETENCIES:
- Detail oriented
- Ability to be successful with an independent work environment
- Excellent interpersonal and communication skills
- Strong customer orientation
- Good command of written and verbal English language.
- Strong computer skills including familiarity with ERP/SAP, Excel, PowerPoint, Teams.
EDUCATION:
- Bachelor's Degree or a minimum of 8+ years work experience within the regulated Medical Device or Pharmaceutical Industry
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.