Job Title: Quality Engineer II 

Department: Quality

Job Reports To (Title): Director, Quality

POSITION OVERVIEW

Ensure adherence for cleanroom monitoring plans, Good Manufacturing Practices, and alignment to procedures and policies with respect to requirements of the sterilization of healthcare products. Assist and take on the responsibilities and critical thinking with respect to the internal quality system processes to ensure the design control and manufacturing of sterile medical products.

QUALIFICATION REQUIREMENTS

• B.S. (or higher) in Engineering or other STEM disciplines required.
  • ASQ, CQE, CQA or CRE certification is a plus.
• Minimum 4 years of experience working in a medical device environment as a quality engineer.
• Minimum 4 years of experience with a quality microbiology background.
• Experience with sterile medical device requirements and environmental testing plans (i.e., bioburden testing, LAL/endotoxin testing, surface monitoring, particle count, etc.).
• Working knowledge with ISO13485:2016, FDA 21 CFR 820, Medical Device Single Audit Program (MDSAP) and other regulatory requirements (i.e., EU MDR).
• Have familiarity with relevant medical device standards to support compliance, that can include:
  • ISO 11135:2014 Sterilization of health-care products — EO—Requirements
  • ISO 10993-7 Biological evaluation of medical devices
• Experience in participating in external and internal audits
• Experience with supplier management, risk management, complaint management, and other Good Manufacturing Practices (GMP).

ESSENTIAL JOB DUTIES

• Taking on the responsibility and applying critical thinking as the representative of the Quality Department to help manage and review environmental testing metrics.
• Help implement and review change management plans that relate to cleanroom and controlled environments that effect sterile products.
• Ensure environmental monitoring plans to manufacture sterilize products are effective, compliant to requirements, and efficient.
• Schedules, conducts, documents, and communicates the results of sterilization and microbiology laboratory tests.
• Ensures that product is tested in a timely manner, minimizing any impacts to production scheduling.
• Ability to provide knowledgeable representation during audits.
• Coordinate and manage remediation tasks in a cross functional team that involve manufacturing deviations, Corrective/Preventative Actions (CAPA), nonconformances from internal and external audits, customer complaints, and supplier evaluation.
• Act independently to determine methods to define problems, interpret data, establish facts, and draw valid conclusions.
• Demonstrate effective communication skills across all organizational levels and motivate people in a positive, constructive manner.
• Demonstrate being detail oriented with strong organizational skills.

Physical and other requirements

• Stooping: Bending body downward and forward by bending spine at the waist.
• Reaching: Extending hand(s) and arm(s) in any direction.