The Product Quality Engineer II will be responsible for product quality engineering, quality assurance, and sterilization activities. This includes assuring that the Microbiology / Sterilization function is maintained per industry standards and that our quality system meets the QSR and ISO13485 requirements.
Essential Duties and Responsibilities:
Develop and maintain strong internal working relationships across Conformis.
Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
Prioritize and plan work activities; adapt for changing conditions
Validate, re-validate, and upgrade sterilization processes in accordance with industry standards. This includes EO, VHP, and Gamma.
Manage and validate upgrades to clean rooms and administer an effective environmental monitoring program
Perform quality testing of CER and Purified water system.
Perform Gamma quarterly dose audit testing per procedures.
Administers the bioburden/endotoxin testing program as required per procedure.
Trend in-process manufacturing data and environmental monitoring data and produce summary reports.
Implement and maintain quality system in accordance to applicable regulatory requirements.
Initiate and participate in resolution of non-conforming materials.
Review Non-Conformity Reports for sub-assemblies and finished goods.
Develop and upgrade procedures for continuous improvement as required by the quality system.
Perform Internal Quality Audits of the quality system.
Develop qualification/validation plans.
Develop and implement statistical sampling plans.
Assist in the investigation of product complaints.
Assist in corrective action investigations.
Other responsibilities as assigned.
Bachelor of Science in Engineering or Science
3-5 years of Quality Assurance/ Quality Engineering and experience in a FDA regulated environment is preferred- with QSR (21 CFR Part 820) experience if possible skills.
Experience in sterilization process management including validation.
Skills, Abilities, Competencies Required:
Excellent written and verbal communication skills.
Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness .
Strong organizational, analytical, and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Must have a solid knowledge of Microsoft Office.
Knowledge of FDA and ISO standards for Medical Devices is a plus. .
Knowledge of Statgraphics or Minitab is a plus.
Conformis is an equal opportunity employer.