Process Quality Leader

1 day ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeEngineering Full time €90,000 - €120,000
Job Title

Quality Engineering Manager - NPI Fixed Term Contract Job Description:

The Quality Engineering Manager - NPI will lead critical projects for new production introduction at a global diabetes care company by providing leadership to a Quality Engineering Team of 5-7 associates managing validation studies and collaborating with various internal and external stakeholders.

Responsibilities:
  • Ensure the company's quality management system aligns with international standards crucial in the medical devices/pharmaceutical industry.
  • Ensure that all activities meet regulatory requirements.
  • Be a key member of the Quality Leadership Team, leading the Quality Engineering Team through daily management, performance reviews, and delegation.
  • Support programs like Six Sigma to enhance processes and product quality.
  • Oversee systems related to production support, such as non-conformance, incident reporting, and customer complaint analysis.
  • Liaise with key external customers to ensure that quality standards meet customer expectations.
  • Ensure Corrective and Preventive Actions (CAPAs) are completed in compliance with regulatory standards.
  • Ensure Good Manufacturing Practice (GMP) compliance in Production and Quality Engineering activities.
  • Prepare and maintain documentation to meet regulatory requirements.

Required Skills and Qualifications:

At least 5 years in an ISO 9001/13485 environment, preferably in the medical devices or pharmaceutical industry. At least 3 years in a supervisory role indicating the need for leadership skills. Understanding of Statistical Process Control (SPC) and Six Sigma methodologies, with Greenbelt Certification being advantageous. Experience with FDA requirements and audits is required. Experience in process validation, sterilization, and cleanroom environments is a plus.

Benefits:

A career at this company means being part of a team that values your opinions and contributions and empowers you to bring your authentic self to work. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. The Total Rewards program which includes competitive pay benefits continuous learning recognition career growth and life balance components is designed to support the varying needs of our diverse and global employees.

Others:

This company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race color religion age sex creed national origin ancestry citizenship status marital domestic or civil union status familial status affectional or sexual orientation gender identity or expression genetics disability military eligibility or veteran status or any other protected status.

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