Quality Systems Specialist II
Becton Dickinson NA

Job Info

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Job Description Summary
As directed by the Quality Systems Manager, the Quality Systems Specialist II is accountable for support of the continued development, improvement and implementation of the Quality Systems as well as maintaining compliance with regulations, standards, and corporate requirements. This position actively participates in quality guidance, product resolution decisions, and statistical problem-solving techniques to supplier quality management, new product development, sustaining product teams, and project and quality network teams for process improvement and continuous improvement activities. This position also supports complaint evaluations, general data analysis for trends, and review of trends with Operations, Quality, Engineering, and the Leadership Team. Additionally, this position may be the Plant Audit Lead and ensures all internal, customer, and third-party audits (regulatory and standards) are successfully completed.

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.

Essential responsibilities include but are not limited to:

• Assist in the selection and qualification of suppliers to provide materials that meet specifications for production requirements.
• Manage operations when nonconformances occur, as needed with accepted quality engineer tools.
• Analyze, summarize, and report site quality performance to management.
• Collaborate with manufacturing personnel to review customer complaints and identify improvements required for conformance.
• Assist with maintenance of the internal audit program.
• Perform internal audits as a part of an audit team and support external audits as needed.
• Participates in applicable CAPA activities to accomplish internal/external objectives.
• Accumulate and prepare quality information reports on a timely basis.
• Give direction concerning product quality using approved documentation.
• Provide site support for the training program.
• Sustaining activities, this person will understand, improve, and control operational processes to realize predictable product flow while satisfying established BD standards of quality. Successful performance requires close work with quality management, operations, suppliers, and/or BD associates to assure compliance with all BD policies, procedures, and practices. Providing critical quality engineering direction to projects with respect to quality engineering tools/principals.
• Performing tasks, of moderate complexity, within planned schedules and timelines, performing and supporting audits, actively leading or participating on project teams, ensuring documentation compliance, and handling customer complaint investigation/resolution.
• Intermediate understanding of quality system policies, procedures, and applications to provide guidance on product or project teams.
• Develop and revise site policies and procedures in accordance with Corporate, Unit, Regional, and Regulatory requirements.
• Develops solutions to routine assigned activities of broad or narrow scope (e.g., Document change, Complaint file entry, CAPA documentation ...), working within or across functions/business units.
• Prepares reports and summaries, including quantitative and qualitative analysis.
• Provide evaluations of all complaints submitted for review by the manufacturing plant or DC and entering the information within the complaint management system.
• Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences / tools both in performing failure analyses from complaint product and identifying trends associated with specific defects or products.
• Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements.
• Establishes a strong working relationship with all levels of operations to appropriately monitor and analyze customer complaint levels, failure analysis, and product reliability to take a lead role in identifying and documenting continuous improvement projects.
• Support Quality Systems compliance and improvement efforts.
• Obey all company policies, standards, and rules, including but not limited to: Safety policies and rules (including lockout procedures); Quality policies and rules.
• Must maintain regular, punctual attendance.
• Performs other duties as assigned by Leadership required to support the needs of the business.

Education:

• Bachelor's degree (Science, Engineering, or similar field) OR a combination of experience and education, required.

Experience:

• A minimum of 3 years relevant experience, preferred.

Knowledge, Skills, and Abilities:

• Project management tools and sophisticated communication skills.
• Intermediate knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g., 21 CFR Part 820, ISO 13485).
• Demonstrated ability to lead, direct and influence people.
• Intermediate training in statistics/data analysis/reporting.
• Audit experience.
• Knowledge in the application of Good Documentation Practices.
• ASQ certified Quality Auditor (CQA) or auditing experience.
• Knowledge of Statistical Methods and Problem-Solving Methodologies.
• Process validation experience preferred.
• Continuous Improvement experience preferred.
• Must be able to speak, read and write English.
• Computer skills (SAP, TrackWise, Excel, Word, PowerPoint preferred) - Intermediate.

Work Environment (if applicable):

• Indoor heated and cooled environment.
• High speed manufacturing environment. Must remain alert and focused.
• May have intermittent exposure to chemicals.
• When on the production floor, noise is a constant distraction and earplugs must be worn.
• Safety glasses and safety shoes must be worn when in required areas.
• Degree of exposure to dust, dirt, heat, fumes, noise, vibration, and chemicals.
• When working outside, any & all physical elements of weather & temperature may be present. Inside, noise is the major distraction.
• Some physical exertion, including lifting, may be required.

Other Functions (responsibilities):

• All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
• This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Associates will be required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.
• Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty successfully.

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.

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Primary Work Location
USA NE - Holdrege

Additional Locations

Work Shift
US BD 1st Shift 8am-4pm (United States of America)

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