Overview of Role:
We have been retained by a Global leader in medical devices to find their next Director of Quality to be located in their large Tijuana, Mexico multi-site operation and reporting to the VP of Quality, Safety and Regulatory, based abroad. This role is responsible for leading quality support to manufacturing operations, including quality engineering, quality control, quality systems and regulatory affairs. Supervises a team of over 70 people. The ideal candidate will work closely with both Mexico and global Quality & Regulatory management teams to ensure business objectives are achieved.
Our medical device client is experiencing strong growth globally, which means their manufacturing operations are expanding and adding sites. In Mexico, our client currently has operations with over a 1000 in headcount and set to grow over 60% in the next 18 months.
This role is critical in the success of this expansion as the person will be involved in developing and growing the team to facilitate the necessary increase in production levels from a quality perspective. The role will be responsible for the existing manufacturing operations, with responsibility growing to support the start-up and operation of multiple manufacturing sites.
Key Areas of Accountability
This role will be responsible for:
- Leading all aspects of quality support to manufacturing operations, including quality engineering, quality control and quality systems (supplier quality, document control, complaint handling, etc.).
- Maintaining and improving systems that ensure compliance to regulatory requirements (including US FDA, MX COFEPRIS, ISO 13485). Acts as site representative with FDA.
- Developing a team of quality professionals that achieve regulatory requirements and strategic business objectives.
- Developing and deploying strategic plans that achieve continuous improvement which enables the company to have competitive edge in manufacturing operations.
- Contributing to the development and deployment of global Quality & Regulatory strategic plans.
Candidate Experience and Skills Required
- 10+ years of experience in the medical device industry.
- 3+ years as Head of Quality Management or Quality Director (responsible for all elements concerning Quality within a medical device manufacturing plant) and experience acting as the site Quality Management Representative.
- Experience in multi-site management is ideal but not required.
- Can demonstrate the effective management and resolution of product quality issues.
- Experience with managing & developing direct reports to achieve a high performing team.
- Strong understanding of global medical device regulatory requirements (with specific expertise in US FDA, MX COFEPRIS and ISO 13485 requirements).
- Experience in managing external regulatory inspections / audits. Preparing for and hosting FDA, surveillance inspections successfully.
- Can demonstrate the creation and execution of quality plans and strategies.
- Experience in plastic injection molding and/or extrusion operations is ideal.
- Ability to communicate effectively with senior management.
- At a minimum, a university degree (Bachelor degree or equivalent) in engineering, science (ideal), business, or similar.
- Fluent in Spanish & English.
Leadership and Skills Required (“the person”)
- A supportive leader with 5+ years managing staff, who is focused on coaching and developing the team. Someone who rates team culture as important.
- Sees the value of Quality as “value adding” and not there to make obstacles.
- Can demonstrate progressing the value of Quality, Safety and Regulatory beyond compliance.
- Excellent communication skills.
- Excellent problem solving skills and a good decision maker (i.e. Can demonstrate making difficult decisions).
- Can demonstrate attracting, retaining and developing talent.
- Can demonstrate the successful management of poor performance.
- Can demonstrate successfully managing remotely.
- Has emotional resilience.
- Excellent time management.
- Ability to lead by example.