Supplier Quality Manager
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
To perform this job successfully, an individual must be able to perform each of the following duties satisfactorily:
- Responsible for Supplier Quality activities across multiple Integra manufacturing sites in Europre, supervising staff across multiple locations.
Perform Supplier Quality audits as required.
Serves as a key point of contact to Quality and Supply Chain partners for Supplier Quality issues, and liaises with the Integra organization to drive timely resolution of Supplier Quality related issues.
The Manager is responsible for management of Supplier Related CAPA, NC, Supplier Corrective Action Requests (SCAR), Audit Observation resolution and metrics reporting.
Lead or participate in Quality Management Reviews and monthly Quality Forums.
Develop and implement visual (real-time) metrics and reporting to drive continuous improvement in the GSQ group.
Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
Plans, coordinates, and directs quality and compliance programs designed to ensure effective and consistent supplier processes with established standards.
The position plays a key role in oversight, development, and approval of process validations at supplier sites.
Additionally, the Manager is responsible for carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including interviewing and training employees, planning, assigning, and directing work; appraising performance; addressing complaints; and resolving problems.
Identifies opportunities to continuously improve quality, compliance, cost and time factors, consistent with Integra business objectives; identifies significant business issues, prioritizes for action, and leads improvement opportunities and problem solutions.
Ensure all Quality records are appropriately filed and easily retrievable in the Quality department.
Collect and analyze performance data against defined parameters.
Perform other related duties as expected.
Skills and qualifications
The requirements listed below are representative of the knowledge, skill and/or ability required for this position:
A minimum of a Bachelor’s Degree in an Engineering, Life Science, or a related technical discipline is preferred. Candidates with an equivalent combination of education and experience will also be considered for the position.
Minimum 8 years of professional work experience in a GMP and /or ISO regulated industry is required.
Minimum 6 years of professional work experience in a GMP and /or ISO regulated industry is required with a Masters Degree.
Experience working in a Medical Device, Pharmaceutical or Biotech manufacturing environment is preferred.
Operations supplier quality experience, with a strong understanding of process validation (IQ, OQ, PQ) highly desired
Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
Strong communication, teamwork, and organizational skills are a must
Strong analytical problem solving and root cause analysis skills
Auditing background is required
Use of Microsoft office tools
Knowledge of statistical techniques
Travel up to 25%
Willing to travel (internationally
Contact
Anna Neema
Le Locle / Home office / Wohlen AG
