The Sr. Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the Standard Operating Procedures and policy's for an organization, such as Quality control, or a manufacturing plant. Develops and maintains schedules and timelines. Ensures the documentation process remains compliant.
The role provides guidance for the various elements of the Quality System, for example, to ensure process control, consistent supplier qualification practices and identifies/recommends opportunities for continuous improvement (internal/external). Moderate level of application of the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of moderate scope and complexity. Will support both internal and external audits.
Responsibilities include monitoring and trending quality indicators for purchased materials as well as manufactured and distributed components/products. Assesses Critical To Quality (CTQ) parameters and risk assessment variables as part of the decision making processes to support predictable product design and flow. Initiates CAPAs and may lead the investigation/corrective action process.
Responsible for day to day QM Engineering responsibilities for product and related operational areas. Is also responsible for assuring departmental compliance with ISO and FDA requirements through supporting plant trainings and initiatives.
Job Description
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.
RESPONSIBILITIES
This specific role will have a focus on site validations of equipment, software and materials.
Develops, documents, administers and maintains Quality Systems for conformance, regulatory requirements and company policies.
Provides advice, updates, and troubleshooting to quality product and processes using technical and enterprise knowledge independently and in team environments.
Uses tools including FMEA, risk analysis, validation, and project management, sampling plans, Six Sigma, control plans, trending and design control.
Initiates and/or supports CAPAs and may lead the investigation/corrective action process
Supports implementation of corrective actions and improvements by initiating and coordinating SAP data/documentation in current products.
Responsible for initiating and coordinating SAP master data and documentation for product changes and new products.
Responsible for validation activities in support of the Baltimore/Sparks reagent plants.
Provide support for routine Quality Engineering responsibilities in the ID/AST manufacturing plant.
Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes.
Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures to support operations day to day.
Supports internal and external audits and assists in administering the audit program.
Develops and maintains efficient methods for regularly reporting to management the current status of product quality with respect to Quality objectives and goals and provides plant quality metrics as required to generate quality system improvements.
Facilitates investigation of customer complaints. Implement revision to TI's based on the result of complaint analysis. Initiates preventative action plans and field action plans in response to valid customer complaints.
Defines Change Control requirements for the plant related to manufacturing, facility and material changes. May provide full support to raw material changes assuring that all Quality Systems and requirements are met.
REQUIREMENTS
5 years' experience within the quality function or Master's Degree with minimum of 3 years' experience in quality.
PREFERRED AND ADDITIONAL SKILLS AND QUALIFICATIONS
Experience with independently writing and executing validation protocols
Experience in a medical device or pharmaceutical manufacturing facility.
Moderate knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) ISO 13485
Clinical Diagnostic experience a plus
Ability and skill to effectively manage multiple tasks and drive execution of change management plans
Ability and skill to lead or manage process control, supplier quality and continuous improvement projects using statistical technique/tools such as: Statistical sampling, SPC
Six sigma, additionally root cause analysis and project management techniques are routinely employed
Ability to effectively write communications that ensures clarity, accuracy and consideration of the audience
Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
Ability to listen to others; including associates, managers, peers and customers when making decisions and solving problems
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 encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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.
Required Skills
Optional Skills
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Primary Work Location
USA MD - Sparks - 7 Loveton Circle
Additional Locations
USA MD - Hunt Valley
Work Shift
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 .
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
