Quality Engineer II

About the role

We are seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Responsibilities

• Ensure manufacturing operations follow all Good Manufacturing Practices and Procedures as defined by ensuring FDA and Quality Standards are met.
• Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified.
• Design, execute and document gage R&R studies.
• Support training on Manufacturing and Quality System documents (SOPs, PIs, MAPs, QAPs).
• Actively lead process improvement events leading to reduction in cost of poor quality (COPQ).
• Reduce scrap and manufacturing waste for various product lines throughout the factory.
• Quality Representative for Material Review Board (NMR) for purchased and make components.
• Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review).
• Investigate and respond to customer complaints and customer issued SCARs.
• Quality Representative for Process Validations and Transfer Validations (may require writing, reviewing, executing, analyzing and reporting on test protocols).
• Prepare quality related deliverables in a timely manner.
• Prepare and execute Engineering studies as needed.
• Responsible for CAPA root cause investigation and actions implementation.
• Implementation of SPC.
• Eliminate All Escapes to the customer. Metric goal is zero.
• Create Controls plans Meet KPI Goals, Quality deliverables.
• Support Quality Culture.
• Lean QMS initiative to reduce Muda by eliminating bureaucratic processes.
• Participate in Quality and Manufacturing Department meetings.
• Collaborate in the clarification of specifications for quality.
• Acts as a consultant for areas related to his/her expertise.
• Support Supplier management process as required.
• Participate and assist as a part of the Internal Audit team as required.
• Other duties as assigned, verbal and written.

Qualifications

• Follow medical device manufacturing best practices (GMP, GDP, etc.), current Nordson Medical policies and procedures, ISO 13485, 21CFR Part 820 and other applicable regulations to ensure compliance to applicable customer and regulatory requirements.

Skills

• Strong problem-solving skills.
• Excellent communication and collaboration skills.
• Proficiency in GMP, GDP, ISO 13485, 21CFR Part 820, and other relevant regulations.

Benefits

Interested? If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

Pay

Nordson Medical offers competitive compensation packages tailored to each position and candidate.

Schedule

Nordson Medical offers flexible schedules to accommodate the needs of our employees.

Contact

If you have any questions about this position, please contact [Contact Information].