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Job Title Head of Quality
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance. In this role, you have the opportunity to We are looking for a strong leader to lead all aspects of quality operations of a new Philips facility for the Drug Coated and Specialty Balloon franchise within Philips Image Guided Therapy Devices. The challenge is to help facilitate the manufacturing transfer from the current facility, build up a new team to support production and quality control, and integrate a fast-growing business in a corporate structure, while enabling market launches and growth. For this you will need excellent influencing skills, in-depth knowledge of relevant Quality Assurance practices, a working knowledge of the regulatory context and understanding of design controls in a combination product environment.You are the main interface between the QA team and business management. Be the key management representative and quality system owner. You facilitate meeting business goals in a compliant manner, and you understand how quality policies and business processes interact. You work closely with Regulatory Affairs, Product Development, Clinical, Operations, Service, Supply Chain and Marketing & Sales.You are responsible for- Building a hardworking team that will support production (e.g., quality engineering, QC, receiving inspection, analytical laboratory)
- Support integration of a recently acquired medical device business in the Philips organization.
- Manage quality improvement and integration plans.
- Lead and mentor the existing quality team (Design Assurance, document control, training)
- Collaborate with other functions and departments on QA related aspects.
- Ensure released products are developed, manufactured, distributed and serviced at the right quality levels, in compliance with relevant regulations and Philips policies.
- Responsible to ensure the adequate release of incoming material, intermediate materials.
- Release of finished devices for clinical tests and delivery to customers.
- Be an 'ambassador' for quality assurance and drive quality awareness and improvement.
- Compliance, effectiveness and efficiency of the QMS and operations.
- Collaborate with Business and Q&R Management to establish strategic plans and objectives
- Establish and supervise quality objectives
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
- You are responsible for compliance of the Quality Management System (QMS) with relevant standards and regulations.
- Bachelor/Master degree with at least 10 years relevant experience in Quality
- Background in a Medical Devices, Pharma, or Combination Products is required
- Proven experience in maintaining compliant Quality Management Systems is required
- Experience with design controls in combination products or med device/pharma environment is required.
- Experience with manufacturing quality control and quality engineering
- Practical knowledge of medical European and US standards and regulations
- Proven track record in integration of corporate quality systems is a plus.
- Excellent verbal and written communication skills (English)
- Strong communication and influencing skills
- ID: #20676760
- State: Minnesota Plymouth 55447 Plymouth USA
- City: Plymouth
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-05
- Deadline: 2021-11-08
- Category: Software/QA/DBA/etc