Position

Sector / Department

Senior Quality Sustaining Engineering Manager (Mexico)

Global Quality Assurance

• 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:

• B.S in Engineering, Science, or related field
• Minimum of 7 years of collective experience in product development, manufacturing and/or quality wiithin a medical device environment
• Strong understanding of medical device risk management (ISO 14971)
• Ability to manage and develop a team
• Proficient with Microsoft Office programs
• Strong understanding of statistical concepts
• Strong understanding and experience with process and test method validations
• Effective working knowledge of domestic and international medical device regulations including 21CFR 820, ISO 13485
• Strong analytical, problem solving, and technical writing skills.

Preferred Qualifications:

• Graduate Degree in Engineering, Science or a related field
• Minimum of 10 years of collective experience in product development, manufacturing and/or quality within a medical device environment
• Experience with EU MDR 2017/745, CMDCAS, SFDA, JPAL MHLW, ANVISA MEDDEV.2.7/1, ISO 60601, ISO 10993 and other regulations/agencies. 
• Lean Six Sigma Black Belt
• Quality RegulatoryCertification eg CQE, CRE, CQM/OE, RAC
• Experience with MDSAP audits
• Working fluency in Spanish