Job Summary

• This role will provide quality engineering support in the development and manufacturing of new and existing equipment and facilities, ensuring compliance with quality system regulations.
• Key responsibilities include leading non-conformance investigations, monitoring production information for risk management, and validating manufacturing processes like IQ, OQ, and PQ.
• Employees are eligible for a comprehensive benefits package including vacation, sick time, holiday pay, and parental leave.

Matching Summary

Salary

$79,000.00 - $127,650.00; Not specified; Vacation –120 hours per calendar year, Sick time - 40 hours per calendar year, Holiday pay, Floating Holidays –13 days per calendar year, Work, Personal and Family Time - up to 40 hours per calendar year, Parental Leave – 480 hours, Bereavement Leave – 240 hours for an immediate family member, Caregiver Leave – 80 hours, Volunteer Leave – 32 hours, Military Spouse Time-Off – 80 hours

Skills & Requirements

Key Requirements

• 2-4 years QA/QE experience in medical device
• Bachelor's degree in Engineering
• Experience with FDA QSRs, ISO13485, ISO14971
• Formal problem-solving methodologies
• Handling non-conforming material
• Qualification of production equipment
• Validation of production processes

Work Rights