Manufacturing Process Quality Leader

JOB SUMMARY

Leads processes and assignments for the Manufacturing Process Improvement team and supports organizational objectives and business goals. Defines project terms to meet objectives and goals of the Manufacturing Process Improvement area. Directs workflow for strategic plans and serves as a primary point of contact for the team. Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.

DUTIES & RESPONSIBILITIES

• Guides team on policies and procedures to ensure compliance and achievement of the organization's objectives for the Manufacturing Process Improvement area.
• Under the direction of the Business Unit Manager, the PQL provides technical leadership towards the Identification of the causes for non-conformances and process’ failures, and for the implementation of the remedial, corrective and preventative actions thus assuring process performance and compliance against QSR, GMP, and ISO requirements for the entire Business Unit manufacturing process.
• Advises on identifying and implementing cost saving measures to drive profit optimization and operational efficiencies.
• Responsible for managing operational aspects of their team (e.g., workflow, performance, and compliance), as well as ensuring achievement of team goals within expected standards.
• Reviews and analyses quality trends with the manufacturing team. Considering the quality trends provides direction in terms of setting work priorities for process enhancement.
• Provides guidance to manufacturing supervisors to ensure the effective in-depth investigations are performed.
• Provides leadership and guidance to cross functional, multilevel technical teams to assure causes of non-conformance are identified and understood and that sound corrective/preventive actions are implemented. Evaluation of the implemented corrective and preventive actions against trends to assess effectiveness of the same.
• Leads investigations of the negative trends and in alignment with the Process Engineer and the Manufacturing Manager, facilities the implementation process.
• Analysis of data and based on the trends recommends actions for process, equipment and system improvement.
• Writes procedures, protocols and any other Documentation needed for the enhancement of processes and systems.
• Provides training and education to the manufacturing team on tools for process evaluation and enhancement. (Analytical trouble shooting, FMEA, statistical concept application and QSR/ISO requirements.
• May lead a number of CAPA and should recommend CAPA’s based on negative trends.
• Handles, prepares data and present product escalation investigations (PRE’s), near misses and QRB.
• Leads in-process investigations with multifunction team to determine root causes and provides recommendations for corrections on preventive actions.
• Handles preliminary investigations of product complaints, analysis, trends and recommendations or leads corrective/preventative actions.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• Performs other duties assigned as needed

EXPERIENCE AND EDUCATION*

· Bachelor Degree in Engineering or Science is required. Master’s Degree preferred.

· A minimum of five (5) years of experience in the QSR/ISO required-regulated medical device operation preferred.

· Experience in a quality role within the manufacturing industry preferred.

· Advanced computer skills (Microsoft Office) and use of software application (s) are required.

· Must have thorough knowledge in QSR, GMP, ISO, knowledge in applied statistics and failure mode analysis techniques.

· Proficient in the preparation of technical reports and presentations.

· Strong communication and interpersonal skills.

· Requires good negotiation skills. Entails heavy interaction with technical peers and manufacturing associates

· Position requires leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail and effective interpersonal skills.

Preferred Skills:

Agile Manufacturing, Benchmarking, Business Valuations, Chemistry, Manufacturing, and Control (CMC), Coaching, Communication, Financial Competence, Good Manufacturing Practices (GMP), ISO 9001, Plant Operations, Problem Solving, Process Control, Process Improvements, Program Management, Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Standard Operating Procedure (SOP), Time Management

Location: Nijmegen, NL