Quality Engineer II (Instrument Plant)

BD (Becton, Dickinson and Company)•Sparks, MD

48d•Onsite

About The Position

The Quality Engineer II is responsible for the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems. The Quality Engineer II uses the Company Quality Systems to ensure overall compliance and has the knowledge necessary to apply the appropriate statistical and analytical tools. Works with variable enterprise systems/Corporate directives to support new and/or current product lines and processes. Typical assignments may include, supporting one or more instrument platforms on sustaining items such as complaints, non-conformances and day to day issues, supporting audits, actively participating on teams, ensures documentation compliance, processing of CAPAs, change controls, and deviation waivers. Frequent interaction with other functional areas such as Research and Development, Operations, etc. is routine. The Quality Engineer II may take the lead in root cause investigations for issues of moderate complexity. We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

Requirements

Bachelor's degree. Typical degrees in Biological Sciences, Chemistry, and/or Regulatory Affairs. Other fields can be considered with the appropriate experience to support the role. An advanced degree can make up for experience requirement.
2+ years' experience in Quality Assurance, Quality Control, or Product/Process non-conformance investigations
Experience in a medical device or pharmaceutical manufacturing facility.
Ability and skill to effectively manage multiple tasks and drive execution of change management plans.
SAP transaction experience.
Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root cause analysis, failure analysis and risk assessment to gather critical information that has moderate to difficult complexity.
Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000 and ISO 13485:2003

Nice To Haves

Familiarity with supplier management, especially SCARs and driving change
Preferable contract manufacturing familiarity
Risk management and risk-based decision making
Familiarity with DHF, DMR, HA, pFMEA, dFMEA, RMP/RMR/BRA
Risk as part of design change - standing up for quality
CAPA and/or process improvement background
Meeting deadlines, achieving effective solutions
Validation involvement - such as a quality advisor/approver
Familiarity with medical device regulations and working in a regulated environment
Preferable first-hand experience with audits
Preferable familiarity with manual assembly manufacturing
Preferable familiarity/background in microbiology/molecular science
Complaint investigation / PMS activities
Data analysis / efficiency
Able to effectively use Excel / PowerPoint / other tools to collect/analyze information

Responsibilities

Maintain International Organization for Standardization (ISO) and regional regulatory requirements. Key elements focus on multiple aspects of quality for product design, manufacturing (assembly and test), inspections and customer complaints throughout the product life cycle.
Develop Device History Files and maintain in a manner consistent with regulatory requirements.
Generate process/product quality information in the form of CTQ (Critical to Quality) indices, recommendations and solutions to emerging issues, to share with project team/operations/suppliers.
Supports the coordinated integration of new products into Manufacturing / Operations.
Ensures BD Diagnostic Systems divisional, departmental policies, procedures, practices and facilities are in compliance with all applicable regulatory policies.
Understanding and coaching others on Quality Systems and procedures.
Perform trend analysis, risk management (such as FMEA, Hazard Analysis, Fault Tree) and six sigma tools.
Cost Center Specific:• Skilled in working in a team environment, ability to perform multiple tasks, effectively manage conflict and drive for results with minimal supervision.
Knowledge of GLP/GMP/ISO requirements and sound understanding of the pertinent Quality System/Regulations.
Computer skills in word processing, spreadsheets and a statistical package required. Must have excellent communication skills.
Knowledge of manufacturing processes, use of statistical tools required, and knowledge of microbiological and chemical test methods are preferred.
Experience using statistical methods is required. Familiarity with Design Control requirements and knowledge of Medical Device Validations is preferred.

Benefits

At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

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