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Group Director Quality Ops Medical Technology

Bothell, Washington 98011 | Direct Hire

Post Date: 03/26/2018 Job ID: 18256 Industry: Hardware

Position Title: Group Director of Quality Operations - Medical Technology

Position Description:  Our Bothell, WA client is looking to bring on a  Group Director of Quality Operations responsible for Medical Technology (Medtech) business units based in Seattle, as well as West and East Coast business units. 

The ideal candidate must be Director level and  silo' ed in pure Quality of Medical Devices, not Director of Med. Devices with quality incorporated in their reports but ALL of their reports are in Quality - a solid Medical Device Quality career path is a must - if you  do have some Pharma that is a huge plus. 

Significant senior level experience in QA with GMP auditing and compliance leadership gained within the Medical Device industry (Pharmaceutical industry - a bonus)  is required for consideration.

Job Responsibilities:

This role will be responsible for leading the Operational Quality Strategy that delivers measurable value for the Medical Technology (the Medtech) business units  by building customer and client satisfaction, creating process simplification aligned with the needs of a ‘ fit for purpose’ Medtech organisation. This will be achieved by delivering Quality Operational Excellence partnering closely with the Director of Operations, Medtech and supporting the Operational Leadership Team. 

This Director  will be responsible for  Quality Assurance / Quality control teams and functions in all   Medtech manufacturing sites. Responsible for the Quality execution of Design Control, NPD and Technical transfer to the Manufacturing Sites.

Broad Function
  1. To plan, direct, lead and control all quality requirements for the Medtech Manufacturing Sites; to achieve improved optimised ways of working aligned with current and future business expansion, cost effectiveness and right first time culture with a focus on continuous improvement and no impact to compliance standards.
  2. Have an active role in the development of global and local policies and procedures to ensure the quality of work in all disciplines. 
  3. Overall accountability and leadership of Quality for the Medtech Manufacturing Sites; ensuring effective  management and adherence to QMS encompassing company policies, procedures and GMP compliance, ensuring compliance to regulatory requirements.
  4. Act as a designate to the Head of Quality; partnering closely with Group Quality Operations Director, SP and IO/IV, Group Quality Services Director and Group Clinical Quality Services Director.
  5. To ensure that the Medtech Manufacturing Sites remain cGMP compliant at all times by strong leadership of the direct team and wider Quality Assurance / Quality Control departments.
  6. Be accountable for directing and implementing appropriate quality practices and standards that are ‘ Best in Class’ and commensurate with both business needs for the Medtech organisation and regulatory expectations, ensuring the strategic quality objectives which have been approved by the Head of Quality and endorsed by CEO and Leadership Team are achieved and where possible exceeded.
  7. Advise key stakeholders on pertinent quality standards and practices and direct the Quality Medtech group in implementing, conducting and/or coordinating GxP auditing/inspection strategies and programmes.
  8. To provide a Quality Assurance service which includes product release, auditing, documentation control,  training, Validation compliance and other QA activities to support cGMP manufacturing operations commensurate with the requirements of a Medtech organisation and regulatory expectation.
  9. To execute plans agreed with Business Leaders and Group Quality Services for the Quality oversight of New Product Development, Design Control and Technical transfer to the Manufacturing Sites.
  10. To provide a Quality Plan to enable manufacturing sites to deliver Quality Operational Excellence.
  11. To lead and support all Medtech Manufacturing Sites inspection readiness preparation and hosting for cGMP agency inspections.
  12. To ensure the Medtech Manufacturing Sites have the resources and systems in place to achieve the Quality System Global Key Performance Indicators.
  13. To recruit, manage, educate and develop employees within the Quality Operational Team to ensure an efficient, effective function exists within the business.
  14. Fully accountable for controlling the Medtech Manufacturing Sites quality budgets, ensuring on-going budgetary accountability to pre-agreed numbers and forecasts; keeping the Head of Quality appraised of on-going status and confirmation of meeting budgetary requirements.
  15. To direct and support the broader compliance agenda within   e.g. aligning with EHS and Commercial compliance.
  16. To ensure that all interactions and engagements are carried out with the highest ethical, legal and professional standards and that all work is accomplished to the required quality standards and in accordance with values and DNA.
  17. Carry out other reasonable tasks as required by the Line Manager.

Principal Relationships
  1. Accountable to – Head of Quality.
  2. Responsible for – Quality Assurance / Quality control teams and functions in all   Medtech manufacturing sites. Responsible for the Quality execution of Design Control, NPD and Technical transfer to the Manufacturing Sites.
  3. Internal – works closely with the Operations Leadership Team and Senior Management, and interacts with all departments and locations.
  4. External – Government Healthcare Agencies, CMO’ s and other third party suppliers.

Education and Experience
  1. Educated to degree level in Life Sciences or equivalent.
  2. Conversant with the regulatory requirements to act as an IMP Qualified Person (QP) or a Commercial Qualified Person. As a minimum eligible to act as a European IMP QP, as required.
  3. Significant senior level experience in QA with GMP auditing and compliance leadership gained within the Pharmaceutical and Medical Device industry.
  4. Extensive experience in both Facility and Product Filing and inspection management with the FDA, MHRA and other Regulatory Agencies.
  5. Extensive experience in the pharmaceutical and medical device industry, with sterile’ s device and pharma experience
  6. Significant experience of technology transfer combined with a knowledge of novel and emerging processing technologies.
  7. Detailed knowledge of Quality systems as well as global GMP requirements and experienced in delivering GMP education and training.

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Gazelle Medina


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