Quality Engineering Manager

Who we want

Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures.
Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.
Quality-focused team drivers. People who motivate their team to deliver the highest quality products and solutions in a timely manner.
Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

What you will do

Responsible for managing the implementation and maintenance of key elements of the Quality Management System to ensure compliance with FDA, ISO, MDD regulations and other applicable standards. May be required to supervise a technical functional area such as Incoming Inspection or Product Disposition.
Help to set departmental goals and priorities and evaluates subordinate’s performance against those goals and priorities. Coach and develop direct report subordinates.
Responsible for 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 in an effective and timely manner with Division and GQ&O leaders regarding effective implementation of nonconformance/CAPA execution and root cause analysis issues.
Assure proper investigation for Root Cause Analysis using effective Root Cause Analysis tools.
Mentor nonconformance/CAPA owners on CAPA Investigations, Action Plans, Root Cause Analysis and Verification/Validation Activities as well as appropriate effectiveness check criteria.
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.
Acts as liaison with external parties on matters relating to the quality system.
Partner with other departments throughout the organization to ensure timely closure of complaints and non-conformances/CAPA.

What you need

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).