Bdx
Quality System Specialist II - Document Control
USA NJ - Franklin Lakes · Mid · Contract
Sponsorship not specified$110k-$176kDetected 4 days ago
SAPFDA RegulatoryMedical DevicesCollaborationProblem Solving
About the role
- Advancing the world of health™ is our Purpose, and it's no small feat.
- This position actively participates in quality guidance, product resolution decisions, Product Development project teams and continuous improvement activities.
- Job Responsibilities: - Supporting the Documentation Management needs for Sustaining Engineering and New Product Development projects.
Responsibilities
- Supporting the Documentation Management needs for Sustaining Engineering and New Product Development projects. This includes processing of Documents, Engineering Change Orders and Design History Files utilizing SAP software.
- Performing tasks, of moderate complexity, within planned schedules and timelines, supporting document retreival for audits, actively leading or participating on project teams and ensuring documentation compliance.
- Develops solutions to routine assigned activities of limited scope & complexity.
- The Quality System Specialist II is accountable for support of the continued development, improvement, and implementation of the Quality Systems.
- We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture.
Requirements
- High School Diploma and 10 years experience OR
- Bachelor's degree in science, engineering, or other relevant discipline and 2 years of relevant experience
- Knowledge and Skills:
- For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19.
- Required Skills
Skills
- Moderate knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g.
- 21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR).
- Moderate level of application of quality system standards to assigned quality system area.
- Ability to use standard and approved Quality/Compliance methods
- Knowledge in the application of Good Documentation Practices
- Contributes to the completion of milestones associated with specific projects.
- Able to prepare reports, including quantitative/qualitative analysis, summaries, and protocols.
- Able to follow established procedures.
- Able to work within and across functions for assigned quality systems.
- Able to provide decisions, recommendations, and results that cause moderate progress in project/program goals and schedules.
- Experience with BD software systems utilized in the Quality Systems is desirable (SAP, Docusign, PEGA, Trackwise).
- Must have knowledge/specialization in Documentation Management
Compensation
- $110,200.00 - $176,400.00 USD Annual
- We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
- Our salary or hourly rate ranges reward associates fairly and competitively.
- Our pay is based on the role and the necessary skills and education to perform it successfully.
- The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location.
- Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Benefits
- BD is one of the largest global medical technology companies in the world.
- We welcome people with the imagination and drive to help us reinvent the future of healthcare.
- Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
- At BD, we reward, support and develop our associates through our comprehensive Total Rewards program.
Company info
- We are the people who give possibilities purpose
Equal opportunity
- Becton, Dickinson, and Company is an Equal Opportunity Employer.
Visa & Work Authorization
- We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientatio
This listing is sourced directly from Bdx's careers page and normalized into a canonical job model.