Director of Quality (Medical Devices)

THE COMPANY

Our client is a publicly traded global leader in medical device manufacturing with rapid and consistent growth, manufacturing critical care products. Global revenue is over $2 billion USD. Due to growth, our client seeks a Mexico Multi-site Director of Quality overseeing three to 4 plants in  multiple cities to join their team and lead their Quality Assurance/Regulatory Assurance department to ensure products are fit for purpose and meet all regulatory requirements.  The company has been in business for over 60 years. Their culture is strongly focused on productivity and quality, while prioritizing teamwork and its people.

THE POSITION

The Quality Director is responsible for Mexico QA Operations (3 to 4 Manufacturing facilities) and will be based in Tijuana, Mexico with up to 20% travel. The role requires a senior strategic leader and technical expert with the ability to manage a broad set of activities as described below.

Key responsibilities

• Leads a diverse group of employees by sustaining an inclusive and empowered organization which is constantly developing and adapting to the current and emerging business needs.
• Provide expert opinion, advice and recommendation to the Global Vice President QA (Manufacturing).
• Responsible to ensure compliant quality systems that meet the business needs at Mexico manufacturing facilities. Quality system documentation should meet the requirements of 21 CFR Part 820, ISO 13485, the European Medical Device Directives/Medical Device Regulation, the Japanese Pharmaceutical Affairs Law, and other international quality system regulations and standards as appropriate.
• Responsible to manage and oversee product QA activities at Mexico Manufacturing facilities, including the day-to-day manufacturing and product quality, regulatory body audits and post market surveillance.
• Leads the combined regional team within Mexico Manufacturing Quality to establish and maintain the Quality System policies, procedures, work instructions and training. associated with the global operational strategy.
• Manages and supports Quality Improvement projects in all areas of responsibility. Constantly delivers improved value for all stake holders by driving and developing a culture of excellence through continuous improvement.
• Supports Supplier Quality Management and partnership with Operations Procurement and Global Supplier Quality teams. Supports Sterilization, Microbiology and partnership with Operations and Global Sterility Assurance team. 
• Sets technical direction for QA in collaboration with Mexico Manufacturing sites and business partners.
• Serves as strategic member of the QARA Global team.
• Provide leadership to all groups that report into the position and actively drives key talent development through coaching, mentoring, development assignments and other formal and informal actions and systems.
• Ensures the focus of every employee within the Mexico manufacturing sites is delivering the highest product and service quality standards to all our customers and their patients in a consistent manner and that the systems necessary to do so are in place.
• Ensure that necessary legal, regulatory and corporate compliance systems are in place and adhered to.
• Define goals in each area of responsibility. Develop specific short-term and long-term plans and programs, together with supporting budgets.
• Provide other departmental support as requested by immediate supervisor.
• Adhere to and ensure the compliance of the Company’s Code of Conduct, all Company policies, rules, procedures and housekeeping standards.

THE CANDIDATE

• Will have a Bachelor of Science Degree in an Engineering, Medical or Science discipline as a requirement. Advanced degree preferred.
• Will come with at least 15 years’ leadership experience in the medical device industry, with at least 10 years’ experience in regulatory and/or quality function(s) commensurate with responsibilities outlined above.
• Is experienced in multi plant operations with regard to compliance with US Quality System Regulations, ISO 13485 and other International requirements. May consider a Quality Director from a large site.
• Has extensive knowledge and understanding of the US Quality System Regulation (21 CFR Part 820),  Medical Device Directive/Medical Device Regulation and the ISO 13485 quality system requirements.
• Has extensive knowledge of quality techniques and practices, as they relate to the medical device industry.
• Has proven audit experience for various regulatory bodies.
• Extensive experience in a matrix management organization is a must.
• Must be fluent in English (Native or bilingual proficiency).