Validation Quality Engineer

Department

Quality Assurance

Director of Quality

Responsible for the validation and revalidation of machines, equipment, material, and process based on defined protocols. Will support activities to maintain and improve the quality management system and ensure compliance with ISO, regulatory, and customer requirements.

• Create, review, and/or update procedures and work instructions.
• Create, review, and/or update product specifications.
• Create, review, and/or revise quality policies, procedures, and systems to help ensure compliance with ISO, regulatory, company, and customer requirements.
• Support supplier control activities including leading or supporting onsite or remote supplier audits, assessments and/or conducting supplier surveys.
• Works with department managers to train personnel on processes and quality procedures.
• Lead and/or participate in change control activities throughout the manufacturing and operations processes.
• Support internal audit process to ensure compliance with ISO standard requirements.
• Perform root cause analysis and develop preventative and corrective actions to eliminate non-conformances.
• Support site production and engineering functions in process quality improvement activities.
• Compile and analyze manufacturing and quality metrics, analyze trends and report to quality management.
• Review, recommend, and support the implementation and use of existing or new test equipment.
• Review and evaluate tool drawings. Inspect tooling before released to production.
• Support and/or manage the NCR/MRB process.
• Develop, create, implement, maintain, and/or modify gauge R&R protocols for test equipment and personnel.
• May lead, support, or follow up on customer complaint investigations.
• Perform other duties as assigned.

• Conduct IQ, OQ, and PQ trials for machine/process/material validations or revalidations.
• Evaluate validation results and create validation reports.
• Develop, update, implement, or modify machine, test, and/or process validation protocols and manufacturing parameter ranges for material combinations.
• Evaluate and validate new materials and/or material combinations.
• Create, review, and/or update machine, material, and process validation procedures.
• Perform other duties as assigned.

• Bachelor’s degree in engineering, science, or related field, associate’s degree in engineering, science, or related field, or at least 5 years of direct experience is required.
• 6 months related experience – this can include professional experience, internships, or organizational involvement is required.

• Experience in and/or knowledge of ISO standards 13485, 9001, or 11607 and/or FDA 21 CFR 820 requirements.
• Education and/or experience with machines, material, and/or process validations (IQ, OQ, and PQ).
• Education and/or experience with medical device manufacturing, medical device packaging, pharmaceutical or other regulated industry.
• Education and/or experience in a high-volume manufacturing environment.
• Education and/or experience with FDA requirements for medical devices and/or cGMP practices.
• Education and/or experience with complaint investigations, risk assessments, root cause analysis, CAPA, Investigations, NCMR, Engineering, FDA, quality engineering, quality assurance, remediation, risk management.
• Education and/or experience with statistical process control, statistical quality control or design of experiments.

• Communication – Ability to communicate with all levels of personnel from production level operators to upper management and customers or suppliers.
• Diversity – Demonstrates knowledge of EEO policy;
  Shows respect and sensitivity for cultural differences;
  Educates others on the value of diversity;
  Promotes a harassment-free environment;
  Builds a diverse workforce.
• Ethics – Treats people with respect;
  Keeps commitments;
  Inspires the trust of others;
  Works with integrity and ethically;
  Upholds organizational values.
• Problem Solving – Identifies and resolves problems in a timely manner;
  Gathers and analyzes information skillfully;
  Develops alternative solutions;
  Works well in group…