Job Description

POSITION SUMMARY:

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.

RESPONSIBILITIES:

MAIN RESPONSIBILITIES: Provide Quality Engineering leadership in direct support of medical device manufacturing. Management and development of Quality Engineers and Technicians. Manage the activities of the Post-Production Quality Engineering team. Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization. Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. Aggressively 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. 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. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

ORGANIZATIONAL INTERFACE: Mentors and supervises others by sharing expertise and providing feedback and guidance. Interfaces within and across company leadership teams. Communicates frequently with organization and outside customer contacts on routine matters. Prepares written communication. Conveys information effectively through formal and informal documents with internal and external team members using appropriate communications protocols. Provides audience-targeted content. Prepares and presents summaries for site quality metrics. Provides approval to proceed with action plans. Establishes networks. Follows through on Quality site goals. Contributes willingly and incorporates the ideas of others. Shares resources, knowledge, and accountability to benefit business objectives, e.g. participates and modulates team meetings. Serves as a leader in Quality reviews. Buildings relationships. Initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others' needs, promoting common goals, and following through on commitments, e.g., helping. Interacts effectively with stakeholders at appropriate levels of the organization. Resolves underlying problems. Identifies a full range of customer/client needs and proposes solutions. makes alterations in products or services to better meet (recognized or unrecognized) customer needs, e.g., partners with an outside vendor to provide a better deliverable.

COMPLIANCE: Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

PROJECT MANAGEMENT: Plans, monitors and assigns tasks requiring conventional types of plans, investigations, and/or interface with other teams. Coordinates and monitors activities/projects. Review plans and monitor the status of implementation for those assigned to the project. Makes judgments regarding the quality of implementation within the discipline. Employs contingency plans to recover from schedule slippage and financial overruns when appropriate, e.g., tracks actual expenditures compared to projected cash flow for own project. Facilitates the definition of a project scope with clients. Estimates and coordinates resources needed (materials, budget, time, and people) to accomplish assigned individual tasks, e.g., coordinates work with technicians and associate engineers. Prepares contingency plans and budgets for assignments. Participates in economic analysis and feasibility studies related to project alternatives. Jointly responsible for achieving the project's financial targets in support of business objectives.

PROBLEM SOLVING/INNOVATION: Provides mentoring on problem solving techniques (e.g., PDCA, DMAIC, etc.). Predicts patterns/trends. Capable of graving complexities and sees relationships among data. Six Sigma Black Belt strongly preferred. ASQ Certified Quality Engineer strongly preferred. Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment. Ability to travel internationally to support international manufacturing sites. Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).