Quality System Engineer

Job Description

TITLE: Quality Systems Engineer

CLASSIFICATION: Exempt

PAY RATE: Will be reviewed at the time of interview

DEPARTMENT: Quality

REPORTS TO: Quality Manager

Position Purpose: This position is responsible for managing the development, implementation and maintenance of quality system related processes and activities. Oversees generation and review of related documents (e.g. used in Good Manufacturing Practices). Supports and/or oversees audits of production and Quality Systems areas. Coordinate interdepartmental activities. Sterilization Process Oversight.

Essential Job Functions-Responsibility & Authority:

1. Sterilization Process Oversight:
2. • Translate SME knowledge to develop, implement, and monitor sterilization processes for medical devices to maintain the highest levels of product quality and safety.
3. • Ensure compliance with industry standards such as ISO 13485, ISO17665, ISO 11135, ISO 11137, and FDA requirements.
4. Work with relevant departments and stakeholders to investigate non-conformances, defects and process failures to identify areas in need of process improvement. Determines the cost of quality and to lead or participate in resolution.
5. Manage and own the Quality Assurance (QA) activities pertaining to Non-Conforming Events (NCE) and Corrective/Prevention Actions (CAPA) for non-manufacturing locations, which includes the control, segregation, labeling and disposition of non-conforming or suspected non-conforming materials at GVS TM third party warehouses.
6. Support Quality Control (QC) Hold Processes by working with manufacturing to understand product issues by providing QA input, communicating hold information to stakeholder groups, and making necessary actions.
7. Provide problem solving in selected projects to improve quality.
8. Manage the Calibration process working with relevant stakeholders.
9. Act as auditor or lead auditor for internal audits, including audit scheduling and liaison, ensure timely follow-up of audit actions and transfer of actions to CAPA system, where appropriate.
10. Provide support to quality processes in other locations to maintain the overall Quality System.
11. Partner with Customer Service, Supply Chain Sales, marketing Legal, Manufacturing and R&D teams as needed.

Job Requirements:

1. BS degree in technical discipline or equivalent training and experience.
2. Two to three years of experience in Quality Systems Engineering and/or Sterilization
3. Post qualification experience in quality with focus on manufacturing and distribution.
4. Demonstrated analytical and written communication skills, effective interpersonal skills, strong verbal communication and listening skills, assumes personal responsibility for actions.
5. Good team player with proficient in English written and verbal communication skills.
6. Willingness to work overtime, including weekends.

Training/Certifications

• List Each Training/Certification

Physical Requirements:

1. Sit; use of hands to finger, handle, or feel objects tools, or controls.
2. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
3. Lifting/moving up to 10 pounds.
4. Exposure to moving mechanical parts, vibration and/or moderate noise levels.
5. Exposure to hazardous chemicals or other materials.
6. Exposure to blood.

Travel Expectations:

• Occasional 10-25%

Benefits:

• 401(K)
• 401(K) matching
• Dental Insurance
• Employee assistance program
• Health Insurance
• Health Savings Account
• Life Insurance
• Paid Time off
• Parental Leave
• Retirement Plan
• Vision Insurance

Schedule:

• 8-hour shift
• Monday to Friday

Supplemental Pay:

• Bonus opportunities

Work Location: In Person