Senior Quality Engineer

About the Role

The Senior Quality Engineer is responsible for monitoring and continuously improving the Quality System Elements. Compliance with company policies, procedures, and the Attendance Policy is essential. This role requires adherence to safety rules, professional conduct, and serving as a role model for safe work practices.

Responsibilities

• Learn and master all necessary areas of the quality system.
• Follow Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Perform batch record review to release products.
• Develop, review, and approve validation protocols and final reports; analyze validation data.
• Assist in deviation resolution and corrective actions.
• Facilitate audit findings and complaint investigation meetings.
• Review and approve complaints, Corrective Action Reports (CAR), and exception reports.
• Act as a liaison between customers and MGS.
• Serve as a subject matter expert on quality system processes.
• Assist in the development of control plans, PFMEA, visual criteria, manufacturing work instructions, incoming inspection plans, and in-process inspection reports for new products.
• Provide disposition of nonconforming products.
• Review and approve engineering change packages.
• Update manufacturing-related procedures and quality system procedures to address gaps.
• Mentor Quality Engineers in their daily tasks.
• Continuously improve the quality system.
• Act as backup for the Quality Manager during 2nd and 3rd party audits.
• Perform internal audits.
• Perform any other duties as assigned.

Requirements

• High School Diploma or equivalent is required.
• Seven to ten years of experience and/or training, or an equivalent combination of education and experience.
• QS/ISO System experience.
• Understanding or working knowledge of ISO 13485 and FDA 21 CFR Part 820 and 11.
• Previous auditing experience.
• Experience with ISO Class 8 cleanroom.
• Experience working with a team, ability to drive change, and influence cultural change.

Competencies

• Positive Attitude
• Teamwork and Cooperation
• Flexibility
• Initiative
• Judgement
• Customer Focused
• Organization
• Attention to Detail
• Ability to Multi-Task
• Critical Thinking
• Communication Skills

Benefits

• Medical, dental, and vision insurance.
• Company-paid life and disability insurance.
• Paid time off.
• Generous 401(k) match.