Sr. Quality Engineer

Job Description

• Develop, modify, apply, and maintain quality standards.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Develop and implement methods and procedures for inspecting, testing, and evaluating products and production equipment.
• Perform statistical analysis of product / process performance.
• Ensure documentation is compliant with regulatory requirements.
• May specialize in design, production control, product evaluation, and / or reliability as they apply to product or process quality.
• Perform and / or review process validation and equipment documentation, including URS, FAT, IQ, OQ, PQ, and TMV (excluding cleaning and laboratory processes).
• Support investigations of manufacturing operations events and assess manufacturing defects / rejects trends.
• Support design requirements validation and manufacturing controls for projects (not Operational Excellence initiatives).
• Other duties may be assigned.

Requirements

Nice to Have

Change Control of Medical Devices.

Equipment Commissioning / Qualification.

Process Validation.

Computer System Validation (CSV).

Experience with Manufacturing, Packaging, and Laboratory Equipment.

Technical troubleshooting experience.

Background in Quality, Process Control, or Assurance within Medical Devices.

Investigation and root cause analysis skills.

Strong technical writing, organization, and communication skills.

Experience developing / updating pFMEA, Control Plans, and Process Flows.

Computer software programming knowledge.

Advanced knowledge in Process Validation and CSV.