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Manager, Quality Assurance
hace 2 horas
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Mammotome, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for developing innovative technology is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. When you join our company, you join in the fight against breast cancer. Working at Mammotome means you will have the opportunity to collaborate with a diverse, hardworking, high-performing team committed to improving patient outcomes. As a trusted leader in breast cancer diagnostics, we invite you to join us and support products you can feel passionate about
Learn about the Danaher Business System which makes everything possible.
The Manager, Quality Assurance is responsible for executing the Quality Assurance function for Devicor Medical Products de Mexico S de RL de CV. Participates in all planning activities and serves as a leader of the QA organization at the manufacturing plant and serves as a key member of the QRA leadership. This position serves as the appointed plant Management Representative.
This position reports to the Director II, Quality Assurance and Regulatory Compliance and is part of the Quality Assurance Department located in Tijuana, Baja California, México and will be an on-site role.
In this role, you will have the opportunity to:
- Responsible for developing, implementing, maintaining, and measuring the effectiveness of the quality system (inspection systems, policies, procedures, testing measurement, corrective actions and internal audits) established to ensure compliance to all applicable regulations and standards (US CFR, ISO13485, CMDR, MDD, JPAL).
- Serves as primary liaison with all regulatory agencies, notified bodies, and other external visitors as appropriate.
- Appointed Management representative for manufacturing facility
- Coordinates the management of quality systems and applicable certifications (US CFR, ISO13485, CMDR, MDD, JPAL, etc.) including the development, maintenance, and update of documentation of process and records.
- Responsible for updating the department with innovations, techniques, systems, measurement equipment's and quality criteria, adapting them to the organization and supervising their implementation.
- Prepares and manages department objectives and budgets and validates and authorizes standard operation procedures (SOP)
- Coordinates maintenance of Controlled Manufacturing Environments (CMEs) through ongoing monitoring programs.
The essential requirements of the job include
- Fluent in English Language
- Experience with Quality Systems.
- Certifications: ASQ, Six Sigma, Lean Manufacturing, (Preferred)
- Knowledge of sterilization processes
- Experience with regulatory agencies (FDA, ISO 13485)
- Between 3 and 5 years as senior level experience
- Education - Professional Engineering title (Industrial Production Engineering or equivalent experience).
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
- Ability to travel – list specifics 20% travel, overnight, within territory or locations
- Must have a valid driver's license with an acceptable driving record
- Ability to lift, move or carry equipment up to ##lb, any other physical requirements
It would be a plus if you also possess previous experience in:
- Experience with Environmental Management System, in accordance with ISO 14001
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
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