Quality Engineer II (Onsite)
Job Description SummaryThe Quality Engineer II performs a variety of compliance related duties associated with the medical devices manufactured at the BD site in Sumter, SC. This position is integral to the design and maintenance of quality systems to meet ISO and FDA guidelines, while working with local, US based and international resources at all levels of the company. The position will build and implement strategic quality plans and regulatory compliant operating procedures supporting routine validation as well as expansion and upgrade projects. Constant evolution to meet the ever-changing technological needs of the healthcare industry provides the quality engineer the opportunity for project ownership and quality system design in the transfer of new processes to the Sumter site. Reports directly to a Quality Manager of the assigned Business Team.
Be Part of Something Bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
A contributing, participating member of the assigned Business Team and a resource to work group & project teams, within the plant and outside the plant relative to quality and regulatory issues.
Maintains familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identifies trends in process and product quality.
Provides technical guidance for projects using the application of pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned. Conducts vendor (equipment and/or raw material) quality evaluations at vendor sites as required.
Ensures the contents of Validation protocols meets all applicable quality system requirements and product requirements. Ensures the protocol is built in accordance with the plan. Define the sampling points, sample sizes and process data to be collected. Ensures the protocol was implemented in accordance with the plan and that the acceptance criteria were met.
Lead projects/project teams in the use of the continuous improvement tools, and methodologies such as Six Sigma, 8D, 5-Why, etc.
Works with assigned manufacturing department (s) to maintain the highest quality standards / requirements. Track and trend quality metrics and assist in the identification of root causes, implementation of corrective/preventive actions and verification of efficiency.
Initiates, reviews, and implements policies and procedures relating to product quality and process control as appropriate.
Ensures that all activities align with government (OSHA, FDA, ISO, etc.) regulations and corresponding policies/procedures including activities and programs as defined in Sumter’s Quality Manual.
Coordinates machine and process capability studies, analyzes data, and submits recommendations.
Coordinates communication between Unit Quality, Unit R&D and plant personnel on new products, product improvements and product issues.
Participates as a team member along with Engineering and Operations’ as required to achieve the overall objectives of the site.
Provides test and statistical support regarding customer complaint issues and makes recommendations on actions to be taken to address the issue.
May lead MWO / PIC initiation, implementation and follow through in support of initiatives within
working with Unit and Site associates to ensure the MWO is approved as required.
ensuring all associates participating in the MWO are trained to complete the MWO.
all MWO requirements are met (required testing is completed, supporting paperwork is collected and reviewed for accuracy and completeness).
supporting documentation / product is forwarded to the requestor (or designee) as required.
Operates within the Safety and QSR guidelines of BD-Sumter.
Performs other duties as assigned, such as Internal Audits, Complaint Investigations, etc. as assigned.
Education and Experience:
Knowledge of validations, IQ, OQ, PQ and DOE tools (required)
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 supervision (required)
BA/BS Degree and 1 year work experience in Quality Assurance/Manufacturing (preferred)
Statistical/investigative tools such as control limits, SPC, significance. (preferred)
Six Sigma training (preferred)
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA SC - Sumter
Work ShiftUS BD 1st Shift 8am-5pm (United States of America)
Recommanderà un ami
Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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