PURPOSE OF THE POSITION

The purpose of this position is to lead a team of quality sustaining engineers at the Mexico manufacturing facilities focused on investigating, addressing and resolving product design and production issues post commercialization.  These activities include but are not limited to: supporting design changes, material changes, and process changes at suppliers, investigation of product non-conformances; communication with suppliers, ensure compliance to quality system requirements and participate insite-to-site transfers. In addition, this role provides quality sustaining engineering leadership by collaborating with cross-functional team (R&D, manufacturing, marketing, regulatory, procurement, distribution) on product improvement opportunities, monitoring and analyzing plant-related complaint data, working on nonconforming product issues,  leading root cause corrective actions, and proactively supporting business strategies. This role will also mentor and coach the Quality Sustaining Engineers at the plants to develop a pipeline of talent.

JOB POSITION ACCOUNTABILITIES

• Provide leadership, direction, management, and development of Quality Sustaining Engineering activities in order to maintain compliance, execute business strategies, and deliver on objectives for all products, processes, and systems in respective franchise.
• Manage self and team in accordance with expected values, behaviors, and accountabilities.
• Drive decision-making efforts based upon technical findings, data, and patient safety.
• Actively participate in and/or facilitate the development of deliverables required to qualify product changes ensuring that regulatory and customer requirements, and specifications are met.
• Actively partner with the manufacturing facilities to ensure adequate process validations are performed.
• Oversee all Risk Management activities associated with the assigned franchise with specific oversight of Risk Management Files, Risk Analysis (FMEAs and Hazards Analysis) for commericalized products in compliance with ISO 14971 and ISO 13485.
• Solve challenging technical problems, provides expertise in related specific field of knowledge and consult on complex issues and projects.
• Utilize Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks.
• Partner with suppliers for assigned franchise to facilitate the completion of product specific Supplier Corrective Actions and to build relationships.
• Provide technical quality oversight for postmarket program in an effort to anticipate risks (User, Patient, Compliance, and/or Business) that could adversely impact a product quality, safety and effectiveness.
• Partner with suppliers for assigned franchise to facilitate the completion of product specific Supplier Corrective Actions and to build relationships.
• Clearly and succintly communicate critical information with internal and external customers/ stakeholders assuring accountability and timeliness of actions.
• Influence and support decision making of cross functional leaders and Senior Management.
• Mentor engineers, business partners, and/ or quality professionals in best practices, industry trends, engineering, validations, quality systems, auditing and communication skills.
• Support site to site transfers, due diligence, integration and remediation activities as requested.

REQUIRED QUALIFICATIONS

EDUCATION: B.S in Engineering, Science, or related field

EXPERIENCE: Minimum of 7 years of collective experience in product development

ENGLISH: Bilingual