Senior Supplier Quality Specialist

Job Description

The purpose of this role is to coordinate the medium to long term Olympus quality strategy for externally sourced specific categories to provide optimised quality assurance and regulatory compliance of externally sourced materials and service.

This role is responsible for ensuring supplier quality management is carried out effectively.  They will provide team activity tracking, bulk & individual supplier reviews, oversight, training, and mentoring to the supplier quality management personnel while also supporting supplier qualifications directly.  Thus, this position will be involved in individual supplier management activities, including Supplier Approval, Supplier (remote) Auditing, Supplier surveys, Supplier Quality Assurance Agreement negotiations, Supplier risk analysis support, and Supplier evaluation support.

Job Duties

• Helps to coordinate Supplier Quality team through spreadsheet lists of relevant suppliers and team member assignments.  Reviews lists for purchase activity, risk categorization, qualification evidence compliance, activity progress, etc.  Solicits updates from teammates.
• Ensures the qualification and approval of suppliers delivering to one or multiple sites in a region.
• Performs regular supplier audits and initiates and monitors required measures.
• Reaches consensus on, and provides the execution of, the debarring / deactivation of suppliers.
• Reviews and updates supplier Approved Supplier List in ERP system.
• Reviews signature requests and facilitates 21 CFR Part 11 compliant signatures with tools like DocuSign, Adobe Sign, etc.
• Pulls lists of suppliers from export services (such as MicroStrategy).
• Supports removal of suppliers from Approved Supplier Lists, where warranted.
• Acts as supplier quality engineering representative in supplier onboarding projects.
• Determines supplier risk categorization based on intended usage.
• Prepares, negotiates in the best interest of Olympus and executes global/regional and local quality assurance agreements on behalf of Olympus and makes sure Olympus commitments are met in all sites.
• Executes remote Supplier audits as lead auditor.
• Prepares, discusses, and reviews supplier surveys.
• Documents decisions on acceptance or rejection of supplier qualifications.
• Drives improvement projects by the supplier.
• Acts as primary interface to supplier regarding supplier-level quality matters.
• Contributes to (regional) category (strategy) boards of the categories providing supplier quality related input.
• Leads supplier improvement projects .
• Supports facility audits by outside agencies (i.e., FDA, ISO/ MDSAP).
• Analyses supplier quality KPIs, makes necessary decisions and proposes actions as required.
• Supports team with execution of above activities.
• Occasionally performs supplied part management such as NC review, SCAR process, Supplier Change Notice management, FAI request/ review, part qualifications, etc.
• Other Quality Assurance responsibilities as assigned by management. 

Job Qualifications

Required:

• BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree.  Experience in similar role(s) may be accepted in lieu of a matching degree.
• Minimum of 5 years’ experience with medical device quality minimum.
  Minimum of 5 years of experience in supplier quality management, including troubleshooting issues. 
• High level of quality tools and methodology skills (e.g. root cause, corrective actions, and verification of effectiveness).
• Functional understanding of the applied interpretation of worldwide regulatory standards and laws applicable to the medical device e.g., ISO, QSR, GMP, jPAL, cCMP.
• Excellent written and oral communication and organizational, project management skills.
• Experience negotiating Quality Assurance (or similar) Agreements. 
• Excellent intercultural skills with diverse cultural approach.
• A self-starter motivated and able to positively motivate others. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside Olympus.
• Focused, target driven with a positive, can-do attitude and a desire to improve patient experience as well as company performance.
• Comfortable in Microsoft Excel, Outlook, and working with online websites.
• Since this is a regional role very good English language knowledge is needed, also to negotiate regional Quality Assurance Agreements.
• Acts independently in line with processes, regulations and norms.
• Since this is a Regional role, the individual will be expected to schedule meetings that work for multiple time zones (global) and well as the ability to do minimal travel (5%) would be a plus. 

Preferred:

• Agile experience a plus.
• Oracle experience a plus.