Quality Engineering, SR Manager CR

Manage the activities, resourcing, and goals of each team to assure operational excellence
• Quality Engineering team shall be able to support product lines including performance of verification and validation, pFMEAs, test method validation, process change risk analysis, and product investigations.
• Plan, prioritize activities including product, process, and quality using engineering methods, to alitn with applicable compliance standards. Lead in identifying risk, developing complex mitigation strategies, alternative solutions,, resolving issues, etc, in collaboration with cross functional groups.
• Ensure and provide technical guidance to cross-funtional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity, including root cause analysis investigations, addressing quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes.
• Identify and lead efforts to optimize quality engineering processes and define and implement core competencies, by assessing business needs to develop, propose and implement solution options.
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 Ensure that investigations, such as OOT, CAPA, IACA, complaints are performed on time, in compliance with procedures, are appropriate to risk level of event, and drive towards root cause solutions.
 Implement quality tools such as: control plans, design of experiments, CpKs, PpKs, Advanced Product Quality Planning, Sampling Plan Calculation, ANOVA, Gage R&Rs, to guarantee that the processes and products comply with the applicable requirements and operational excellence principles.

RESPONSIBILITIES TO PEOPLE ON TEAM

- Manage the goals of each team to foster operational excellence and instill quality at the source while aligning with Quality and Site objectives

- Lead team building and engagement using approaches such as: One on one meetings, open sessions, recognition based on results, positive confrontation, open door policy, effective listening, assertive communication, among others, to foster an adequate work environment

- Provide resource and personnel administration for team and individuals including but not limited to: recruiting, job description development, Individual Development Plans (IDP) activities.

- Coordinate budget forecast, approval, monitoring of adherence, and assessment to adjust for all teams.

- Support and promote the implementation of EHS programs to ensure people safety and environment health.

RESPONSIBILITIES TO CROSS FUNCTIONAL CUSTOMERS

- Participate as a leader with cross functional colleagues to influence and impact overall approach to product quality, activities include containment meetings, planning meetings, significant event resolution, kaizen events

- Develop quality team leaders who create actively engaged quality team members who contribute to operational success while assuring compliance to processes and regulations.

- Lead, develop, control, analyze and communicate metrics on different meeting levels (1, 2 & 3), to foster operational excellence among current processes,

- Support internal and external audits from Regulatory entities and Notified Bodies to guarantee the commercial distribution of products manufactured by Costa Rica facility.

- Support implementation of cost reduction projects

- Maintain, improve, and simplify procedures, processes, and methods