Sr. Quality Engineer

Mg Staffing Group

5d

About The Position

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

Requirements

• 3–5 years of experience in a regulated industry (Medical Devices, Pharma, or Biotech).
• Experience with Risk Management documentation (pFMEA).
• Basic knowledge of statistics (preferably using Minitab).
• Knowledge of validation strategy design (requirements flow-down from design to manufacturing).
• Bachelor in Engineering completed
• Experience in CAPA, investigations, and technical writing.
• Knowledge of Medical Device regulations.

Nice To Haves

• 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.

Responsibilities

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level