Quality Engineer II

BD (Becton, Dickinson and Company) Burlington, NC

About the Job

# Job Description SummaryThis position is responsible for working as part of the Quality team at the Burlington manufacturing plant\. Activities will include, but are not limited to: processing and investigating complaints, managing and updating risk management documentation, providing production QE support, gathering and presentation of metrics, process review, product/part review, and documentation creation and revision\. Additionally, the Quality Engineer functions as a subject\-matter resource for Engineering, Operations, and issue investigation\. # Job Description **RESPONSIBILITIES** **:** + Represents the company in a professional manner\. Provides support to Project Teams and Quality Department\. + Responsible for all product complaint investigation in the complaint system \(Trackwise\)\. Manages completion of assigned complaint investigation files within a timely fashion\. Creates, reviews and approves Quality System Documents \(CAPA, Audits, procedures, work instruction, product non\-conformancies\)\. + Develops and maintains a working knowledge of BD policies and procedures and regulatory requirements\. Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis\. + Performs tasks accurately and with great attention to detail\. Interfaces with manufacturing, engineering, product support and divisional groups\. + Ability to perform engineering work of a broad nature with little or no direction from Quality Management\. + Generally, receives guidance on novel or controversial problems\. + Basic knowledge of medical device regulations, industry or international standards\. + Basic knowledge of Medical Device complaint processing requirements\. + Basic knowledge of Risk Management standards and application\. + Basic knowledge of manufacturing processes\. + Excellent communication skills \(verbal, written, and presentation\)\. + Understands how to present information dependent upon the level of the audience\. + Understands Fundamentals of Engineering Principles\. + Ability to effectively manage time and manage priorities to meet deadlines\. + Ability to handle multiple task assignments\. + Ability to interpret Corporate, Division and Department Procedures\. + Ability to work with minimal supervision\. + Ability to work in a team\. **REQUIREMENTS:** + Bachelor's degree in science, engineering, manufacturing technology or closely related field\. + Minimum 3 years experience in Quality Assurance or Quality Engineering\. + Failure investigation methods and tools knowledge\. + Excellent attention to detail\. + Working knowledge of medical device manufacturing regulations and standards\. \(i\.e\.: FDA 21CFR820, ISO 13485, ISO 14791, etc\) **PREFERRED AND ADDITIONAL SKILLS AND RESPONSIBILITIES:** + Must be proactive and have strong interpersonal and project management skills\. + Ability to work both independently and in partnership with others\. Proven ability to use initiative and drive to achieve results\. + Experience in complaint processing and investigation\. + Experience with mechanical inspection + Experience in risk management requirements and documentation\. + Six Sigma Black Belt Certification preferred + American Society of Quality \(ASQ\) certification \(CQE, CQA, etc\) # Primary Work LocationUSA NC \- Burlington \(Tripath Imaging\) # Additional Locations # Work Shift1st Shift 7am\-530pm Mon\-Thu \(United States of America\) 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