Hologic Supply Chain Quality Assurance Manager in Belgium
Supply Chain Quality Assurance Manager
Post Date Sep 24, 2018
Responsible for providingleadership and technical support to assure quality compliance related to all supply chain activities within EMEA.
This function deliversthe implementation of quality to ensure capability for operations and distribution.This will be applied throughassuring Compliance with international and corporate supplier management processes and any other applicable regulatory requirements.
This role oversees, provides guidance and take ownership for the application of supply chain QA practices and techniques to specific situations,to ensure new suppliers, distributors and warehouses are chosen based upon assessment for business requirements and to ensure all quality activities and communication with the suppliers are completed including but not limited to validation, product verification, audit and any other required activities deemed neededto ensure the continuing suitability, adequacy and effectiveness of Hologic’s Quality System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Provides leadership, technical support and ownership to all aspects of supply chain quality in EMEA to address product related quality issues through daily interactions
Implement all GDP (Good Distribution Practices) to all supply chain of all Hologic and third party products within EMEA.
Communicates current and applicable regulations applicable for the supply of Hologic products and services
Leads team to create documentation associated with quality supply chain activities including but not limited to :supplier agreements, supplier files , and supplier assessments/audits.
Ensures and owns execution of activities to support change control activities and document management requirements by collaborating with applicable departments and peers to define requirements for individual projects
Responsible for technical investigations plans, reports and related procedures which ensure validity, adequacy and compliance to regulatory and corporate requirements
Attend and lead regular communication meetings with cross-functional teams to identify the root cause of problem and create remedial plans for short-term and long-term resolutions
Provide leadership in the preparation of risk assessments using tools such as Failure Mode and Effects Analysis (FMEA)
Supports the delivery of system solutions by assuring activities are conducted in a compliant but cost effective manner. Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations
Develop and manage supply chain quality KPI’s for thecorporate metrics
Participate in the EMEA Management Reviews
Perform other related duties as assigned
EDUCATION AND EXPERIENCE
BS or equivalent in scientific discipline, engineering, or related discipline with the required skills, knowledge and abilities that are typically acquired through experience in supply chain quality environment in the medical device or pharmaceutical industries
Must be proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements (9001 / 13485)
Must have advanced knowledge of supplier quality requirements and extensive knowledge in GDP
Proficient in spreadsheets and word processor applications
Proficient in concepts of statistics, sampling plans and statistical analysis
Ability to independently plan, execute, and/or problem solve moderate to complex situations
Ability to exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Must demonstrate leadership attributes
Solid oral and written communication skills
Ability to manage multiple projects
Good written and oral communication skills are required, for example to ensure succinct report generation, effective communication with staff, peer groups, etc. across organisation
Computer literate - knowledge of Word, PowerPoint and Excel an advantage - in order to produce reports, analyse data etc. effectively
- Flexible working hours and travel is required for business requirements
Responsible for ensuring that related supplier quality activities comply with current regulations
Team achieves site and company goals and objectives