Sr Quality Manager

MAIN PURPOSE OF ROLE
Summarize the main purpose of the 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.
This individual develops and executes the required strategies and plans to improve product and process quality in order to deliver planned business results and assure compliance with FDA and ISO
regulations and any country specific regulation were product is distributed.
This position is responsible for collecting and documenting management review information, conducting regular meetings, and reporting the information to the
plant's leadership team and the appropriate Divisional Management Representative.
This position may be appointed with the responsibility of Management Representative for the business unit.
**MAIN RESPONSIBILITIES**:

- Quality Management Representative to all external entities interacting with the Costa Rica site for the business unit.
Responsible for reporting on the status of the quality system to the Management with Executive Responsibility.
- Management and development of applicable Quality department personnel.
- 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 superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines - Critical Parameter Management.
- 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 facility's implementation of and compliance with Nonconformance and CAPA systems.
- 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.
- Prepare the department budget and salary plan revisions.
Prepare the department objectives for the fiscal year.
This includes project plans, training, development, and other specific work plans.
- Verify adherence of New Product Introductions to the established Quality System, international standards and agency regulations.
- Accomplishes results through lower level subordinate supervisors or through experienced exempt employees who exercise significant latitude and independence in their assignments.
- Assignments are received in objective oriented terms.
Provides guidance to subordinates based on organizational goals and company policy.
Work is reviewed in terms of meeting the organization's objectives and schedules.
- Interprets and executes policies and procedures that typically affect subordinate organizational units.
- Recommends modifications to operating policies.
QUALIFICATIONS
- Bachelor's Degree (4-year degree) Engineering, Science or Technical Field, or Business Administration.
- 7 years of experience in Quality Engineering roles.
- 10+ years of experience with at least 5+ years in a Manager role.
- FDA Class II or Class III medical device experience.
- Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies required.
- Demonstrated organizational influence to include, but not limited to: compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
- 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.
- Ability to travel to support domestic and international manufacturing sites (up to 25%).
- Fully Bilingual (English and Spanish) / Required

Preferred Qualifications & Education
- Master´s degree.
- 10+ years in Quality with roles of increasing responsibility, impact, and scope within a manufacturing support environment preferred.
- Quality or Lean Certifications (i.e.
Six Sigma Belt, ASQ CQE/CRE/CQM) preferred.
- Lead Auditor/Audi