Sr. Manager, Supplier Quality Engineering
Company: Integra LifeSciences
Posted on: July 23, 2021
- Responsible for Supplier Quality actvities
within the CSS division, managing staff across multiple
- 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.
- 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
- 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
- The SQM is responsible for management of
Supplier Related CAPA, NC, Audit Observation resolution and metrics
- Additionally, this manager is responsible for
carrying out managerial responsibilities in accordance with the
organization's policies and applicable laws; including
interviewing, hiring, and training employees, planning, assigning,
and directing work; appraising performance; addressing complaints;
and, resolving problems
- Ensure all Quality records are appropriately
filed and easily retrievable in the Quality department.
- Participate in Quality Management Reviews and
monthly Quality Forums.
- Collect and analyze performance data against
- Provide leadership and guidance in the areas of
CAPA, non-conformances, Product complaints, and document control.
Perform other related duties as expected.
- A minimum of a Bachelor’s Degree
is required, engineering or other technical discipline highly
preferred. An equivalent combination of education and experience
will also be considered.
- Minimum 10 years of professional
work experience in a GMP and /or ISO regulated industry is
- Experience working in a Medical
Device manufacturing environment is strongly
- Strong ability to create and
approve manufacturing process validation protocols is
- Strong communication and
leadership skills are essential, including experience leading teams
- Operational Supplier Quality
experience is required.
- Knowledge of Medical device
standards and regulations such as ISO13485, 93/42 EEC, 21 CFR Part
- Strong communication, teamwork,
and organizational skills
- Strong analytical problem
solving and root cause analysis skills
- Auditing background is
- Use of ERP, PLM
- Use of Microsoft office
- Knowledge of statistical
- Experience or knowledge with the
machining processes, injection molding, and/or electromechanical
medical devides is strongly preferred
Keywords: Integra LifeSciences, Boston , Sr. Manager, Supplier Quality Engineering, Other , Mansfield, Massachusetts
Didn't find what you're looking for? Search again!