Quality Engineering Manager

hace 2 días

Tijuana, Baja California, México Stryker Corporation A tiempo completo

**Key Responsibilities**

  • Oversee the implementation and maintenance of the Quality Management System to ensure compliance with FDA, ISO, MDD regulations and other applicable standards.
  • Supervise technical functional areas such as Incoming Inspection or Product Disposition.
  • Help set departmental goals and priorities, and evaluate subordinate's performance against those goals and priorities. Coach and develop direct report subordinates.
  • Ensure inter-departmental compliance with company policies and corrective actions.
  • Manage the Corrective Action/Preventative Action (CAPA) system for the division, including the CAPA Review Board and all activities.
  • Develop and implement plans/programs to meet quality objectives.
  • Communicate effectively and timely with Division and GQ&O leaders regarding nonconformance/CAPA execution and root cause analysis issues.
  • Mentor nonconformance/CAPA owners on CAPA Investigations, Action Plans, Root Cause Analysis and Verification/Validation Activities.
  • Ensure reporting needs under Medical Device Reporting (MDR) requirements are met.
  • Collaborate with Post-Market Surveillance activities.
  • Conduct and participate during internal/external audits.
  • Create a culture of partnership, transparency, service and collaboration with field personnel.
  • Maintain procedures to ensure compliance to corporate policies and FDA/ISO/MDD regulations.
  • Provide periodic trends and reports to assist in process improvements and for management review.
  • Collaborate on supplier audits.
  • Support Quality Assurance in external FDA audits and other 3rd party audit support.
  • Address non-conformities from internal and external audits.
  • Report on the performance of the quality system for review and as a basis for improvement of the quality system.

**Requirements**

  • Bachelor's degree in Engineering preferred.
  • At least 7 years of work experience in Quality Assurance, being 5 years in a Medical Device manufacturing environment.
  • 3 to 5 years experience in managing technical personnel and complex activities.
  • Demonstrated track-record of accomplishments as a Quality Assurance Manager, and with satisfying customers in technology-driven, developing companies.
  • Experience with FDA and international Quality System rules, regulations, including planning and implementation.
  • Excellent interpersonal skills, ability to work with individuals across all levels of management and customers.
  • Demonstrated effective managerial skills and strong team leadership skills.
  • Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment essential.
  • Excellent analytical skills, data collection, management and reporting skills.
  • Quality Systems knowledge (QSR, ISO 13485:2003, MDD).
  • Certified Auditor recommended.
  • Six Sigma Green Belt recommended.
  • Systems knowledge is a plus (MES, SAP, onePLM, Trackwise, Valgenesis among others).
  • Database Management and Statistical software (e.g. MiniTab) is recommended.
  • Fully Bilingual (Spanish & English).

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