Validation Quality Engineer

Job Description

Job Description

DEPARTMENT : Quality Assurance

REPORTS TO : Director of Quality

SUMMARY : 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.

DUTIES AND RESPONSIBILITIES :

Quality Related 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.

Validation Related Requirements :

CANDIDATE REQUIREMENTS :

PREFERRED EXPERIENCE AND SKILLS :

COMPETENCIES :

PHYICAL DEMANDS AND WORK ENVIRONMENT :

COMPENSATION AND BENEFITS :

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Each candidate for this position must have a clean and neat appearance, observe good personal hygiene and conform to the dress code in keeping with SteriPax’s clean manufacturing environment.

I have reviewed, understand, and able to perform with or without accommodation the requirements as described in this this job description.