Talent Experts LLC Looking for Quality Engineer at Remote Full Time

Job Summary

The Quality Engineer III validates analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification. Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process-related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.

Essential Duties and Responsibilities

The incumbent maybe asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Provide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.

• Author master validation plans and reports.

• Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).

• Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).

• Determine validation strategy based on acceptable risk-based approach.

• Lead cross-functional team to write PFMEAs.

• Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).

• Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.

• Provide technical support (subject matter expert) during audits (internal and third-party).

• Assist in external audits for suppliers or third-party vendors.

• Review regulatory submissions and/or notifications.

• Propose, plan and execute improvement projects.

• Develop/update departmental procedures and other controlled documents.

• Evaluate adequacy of specifications for new or modified process designs.

• Lead department and cross-department projects. Determine QE deliverables and assist in generating project timelines.

• Participate in process design reviews.

• Participate in Material Review Board (MRB) and Production Response Team (PRT) meetings.

• Participate in department process improvement goal(s).

• Assist in development, maintenance, and reporting of department metrics.

• Assist in developing and implementing policies.

• Provide management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

• Train and mentor new employees. Provide guidance and direction to the team.

• Assist in managing team’s priorities and workload.

Requirements
Education

• Bachelor’s degree in Science or Engineering.

Experience

• Five to eight years of experience in in-vitro diagnostic, medical device, biotech or pharmaceutical industry.

Skills

• Expert in validation methodology and risk evaluation techniques.

• Experience with process validation, analytical methods validation, cleaning validation, facilities/utilities and equipment qualifications.

• Experience with change control process and documentation requirements.

• Experience with electronic document management systems.

• Understanding of statistics, SPC and acceptance sampling.

• Experience with risk analysis and PFMEA.

• Advance knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).

• Advance knowledge of 21 CFR Part 11.

• Strong project management skills.

Job Type: Full-time

Pay: $110,000.00 – $120,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: Remote