BD is seeking a Quality Engineer II to join the team at our medical device manufacturing site in Sumter, SC. As a Quality Engineer II, you'll play an integral role in maintaining compliance with ISO and FDA guidelines while collaborating with local, US-based and international resources. You'll be responsible for building and implementing strategic quality plans and regulatory compliant operating procedures that support routine validation, as well as expansion and upgrade projects. If you're passionate about quality and are looking for a challenging and rewarding career, we want to hear from you!
Serve as a resource to work group and project teams, within the plant and outside the plant relative to quality and regulatory issues.
Maintain familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.
Provide technical mentorship for projects using the application of pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned.
Ensure the contents of Validation protocols meet all applicable quality system requirements and product requirements.
Lead projects/project teams in the use of continuous improvement tools and methodologies such as Six Sigma, 8D, 5-Why, etc.
Work with assigned manufacturing department(s) to maintain the highest quality standards/requirements.
Initiate, review, and implement policies and procedures relating to product quality and process control as appropriate.
Ensure that all activities align with government (OSHA, FDA, ISO, etc.) regulations and corresponding policies/procedures.
Coordinate machine and process capability studies, analyze data, and submit recommendations.
Coordinate communication between Unit Quality, Unit R&D, and plant personnel on new products, product improvements, and product issues.
Provide test and statistical support regarding customer complaint issues and make recommendations on actions to be taken to address the issue.
Lead MWO / PIC initiation, implementation, and follow-through in support of initiatives within the assigned business team.
BA/BS Degree (Major: Engineering, Sciences, Mathematics, or equivalent) (Required) Mechanical Engineering Major (Preferred)
Minimum of BA/BS Degree AND 3 years work experience in Quality Assurance/Manufacturing OR MSc. Degree AND 1 years work experience (Required).
Solid understanding of statistical/investigative tools such as control limits, SPC, significance studies, P charts, probability studies, 8D, 5-Why etc. (Required)
Effective written and verbal skills with the ability to accept responsibility and perform responsibilities with minimal direction. (Required)
Working knowledge of Validations, IQ, OQ, PQ, and DOEs (Preferred)
Solid understanding of QSRs / ISO13485:2016 (Preferred)
Six Sigma training (Preferred)
Jobs
