JOB DESCRIPTION: MAIN PURPOSE OF ROLE This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.
MAIN RESPONSIBILITIES:
- Management and development of Quality Engineers and Technicians. • Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
- Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
- Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
- Define and implement Process Control & Monitoring systems.
- Provide influential peer leadership with international partner site to drive proactive quality improvements.
- Identify Quality Initiatives and lead cross-functional teams to complete them.
- Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
- Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
- Oversee the Nonconformance and Real-time data management portions of the Quality System.
- Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
- Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
- Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organization.
- Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.
- Perform other duties and responsibilities as assigned by senior management.
QUALIFICATIONS
- Bachelor's degree (4-year degree).Engineering, Science or Technical Field, or Bachelor's degree in Business Administration.
- 5 to 7 years of experience with preferably 4+ years in a quality engineering roles.
- Solid knowledge of and experience working with international quality regulations, including US 21 CFR 820 (QSR) and ISO 13485.
- Demonstrated and impactful experience with product and process qualification and validation, process improvement, lean and six sigma methodologies, process control and monitoring (SPC).
- Demonstrated results in nonconformance management and reduction, value improvement, risk reduction, and cost containment.
- Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
- Excellent English required.
- Ability to travel to support domestic and international manufacturing sites (up to 15%).
JOB FAMILY:
Operations Quality
DIVISION:
SH Structural Heart
LOCATION:
Costa Rica Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2
ADDITIONAL LOCATIONS:
WORK SHIFT:
Cr09Sal (Costa Rica)
TRAVEL:
Yes, 15 % of the Time
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
