Summary of Position with General Responsibilities:
Responsible for performing various aspects of QE/QA/QC from performing routine QA/QC functions to providing QA Plans for new products in support of R&D teams which includes sterilization validation, qualification activities and verification and validation requirements. Runs IQ/OQ/PQ’s in conjunction with project team.
Essential Job Functions:
Serves as a team member to provide quality engineering expertise to R&D project teams, continuous improvement teams and manufacturing support.
Ensures design control compliance and required documentation for R&D projects.
Maintains Company compliance of FDA Quality System Regulations and ISO: 13485 standards.
Conducts failure and hazard analysis for R&D projects and for manufacturing support.
Conducts internal quality and external supplier audits.
Assists in the Company’s complaint and failure investigation process.
Generates corrective action plans, monitors and assists as necessary to ensure completion.
Manages test protocol and report development for validations.
Develops inspection and process control procedures, process through document control and provides training for the procedures.
Participates on teams responsible for the procurement and installation of manufacturing equipment and parts.
Performs special projects and other duties as assigned.
Education and/or Experience:
Bachelor’s degree in Engineering, Quality Assurance or related discipline.
Minimum five (5) years experience in quality engineering with a medical device and/or pharmaceutical manufacturing company.
ASQ CQE certification preferred.
Background in chemistry, biology, and/or analytical testing preferred.
Must have DOE, Statistical Analysis, Quality System implementation, Quality Engineering Techniques, IQ/OQ/PQ, QSR (GMP) and ISO 13485:2003 experience.
Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project management skills.
Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team oriented environment and maintain critical relationships with contractors, suppliers and investors.
Ability to thrive under challenging deadlines and in an energetic environment.
Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.
C. R. Bard - 18 months ago
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