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BD (Becton, Dickinson and Company) Quality Assurance Compliance Specialist II in Sandy, Utah

Job Description SummaryThis position is responsible for overseeing and administering the CAPA system. The position provides tools and training to CAPA users to ensure thorough investigations and timely completion of all actions.

The Quality Assurance Compliance Specialist is responsible for overseeing the internal audit program. This position plans the required annual internal audits. The Quality Assurance Compliance Specialist will conduct internal quality system audits as the Lead Auditor. The position will manage Audit Non-Conformity Reports (ANRs).

Job Description

RESPONSIBILITIES

  • Oversees the site CAPA system and ensuring timely completion of corrective actions.

  • Manages the CAPA review board meetings

  • Develops CAPA data reports and provides to management

  • Provides CAPA training to associates

  • Manages internal audit program including: Audit schedule development, ensuring audits are conducted to schedule, monitoring the completion of ANRs.

  • Participates in the development of solutions to Quality System problems and/or non-compliance.

  • Participates in the planning, preparation and execution of FDA, notified body and corporate quality system audits.

KNOWLEDGE AND SKILLS

  • Advanced organizational and planning skills. Excellent follow-through capabilities.

  • Knowledge and experience of Quality System auditing processes and techniques including planning, execution, reporting and follow-up skills necessary for the Lead Auditor

  • Thorough knowledge of FDA, ISO, JPAL, CMDR, TGA and MDD Regulations.

  • The ability to concurrently handle a variety of projects and coordinate the efforts of employees.

  • Strong skills in communicating with all levels of technical and operating management.

  • Ability to work in a cross-functional team environment.

  • Superior written and oral communication skills.

  • Ability to work independently with minimal supervision.

  • Excellent analytical skills.

  • Advanced organizational and planning skills. Excellent follow-through capabilities.

  • Knowledge and experience of Quality System auditing processes and techniques including planning, execution, reporting and follow-up skills necessary for the Lead Auditor

  • Thorough knowledge of FDA, ISO, JPAL, CMDR, TGA and MDD Regulations.

  • The ability to concurrently handle a variety of projects and coordinate the efforts of employees.

  • Strong skills in communicating with all levels of technical and operating management.

  • Ability to work in a cross-functional team environment.

  • Superior written and oral communication skills.

  • Ability to work independently with minimal supervision.

  • Excellent analytical skills.

MINIMUM REQUIREMENTS

  • (3-5) years of related quality experience in the medical device industry, or equivalent.

  • A strong knowledge of quality systems including FDA, ISO, JPAL, CMDR, TGA and MDD regulations

  • Strong project management skills

  • Demonstrated written and verbal communication skills

  • Strong analytical and problem solving skills relative to the areas listed in position summary.

PREFERRED REQUIREMENTS

  • Bachelor's Degree in STEM or equivalent

  • Third party Lead Auditor certification is preferred.

  • Experience with Trackwise eCAPA preferred.

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.

Primary Work LocationUSA UT - Sandy

Additional Locations

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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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