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Quality System Engineer

Apply Now Job ID R-333363 Date posted 06/17/2019

Job Description Summary

The position will support Quality Compliance functions within Quality Systems. Establishes and maintains the necessary quality programs to ensure the Company meets the Quality System requirements per company procedures and applicable federal regulations and international standards

Job Description

Essential Duties and Position Responsibilities

  • Execute and administer activities associated with Quality Systems requirements including, but not limited to, CAPA, investigations and remedial actions. Serve as site CAPA coordinator.
  • Oversee the corrective and preventive action system (CAPA) and analyzing the results of the implemented actions in order to verify that the realized solutions were effective and determine if the scope of the action is broad enough.
  • Maintain systems for tracking CAPAs and Audit findings and perform trending activities and provide information as appropriate to management.
  • Participates in CAPA Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence.
  • Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
  • Partner with cross-site and cross-functional resources in the pursuit of continuous improvement, and provide quality systems guidance as necessary.
  • Execute product Post Market Surveillance activities as needed.
  • Conducts and participates in internal and external Quality System audits to assess the compliance with FDA regulations, ISO standards, EU MDR and any other international regulations and internal requirements.
  • CAPA and Audit results reporting, analysis and presentation of activities, and perform follow up and tracking of corrective actions taken.
  • Acquire and analyze information for the purposes of authoring and reviewing technical documents along with informational and decision-making management reports.
  • Maintain and adhere to departmental processes and systems to ensure regulatory compliance.
  • Complete mandatory training by established due dates.
  • Supports the generation, publishing, trending, and monitoring of Quality metrics

Qualifications, Knowledge, and Skills Required:

  • Bachelors Degree in Engineering or other technical discipline equivalent required.
  • 2-5 years of experience in quality systems/engineering preferably in the medical device, pharmaceutical or biotech industry.
  • Working knowledge and application of quality tools, methodologies and software (i.e. Is/Is Not Analysis, 5 Whys, Cause and Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.) in the areas of investigations and CAPAs.
  • Applied Knowledge of the requirements of FDA QSR, ISO13485:2016 and ISO 14971:2012 as well as a thorough working knowledge of all major global quality system requirements (US, EU, Canada, Japan, Australia) for medical devices.
  • ASQ CQA certification preferred.
  • Proficiency in common computer applications such as Microsoft Office (Excel, Word and PowerPoint).
  • Good interpersonal and team player skills including ability to interact with high degree of diplomacy with representatives from a variety of disciplines.
  • Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
  • Self-motivated, self-disciplined and able to prioritize and handle multiple tasks and responsibilities.
  • Willing to accommodate some travel as needed

Key Relationships

Internal Relationships

- Quality Systems

- Quality Managers/directors

- Production Supervisors & Managers

- Manufacturing Engineers

- Product Managers

- Product Development Managers/Engineers

- Purchasing

External Relationships:

- Functional and corporate management

- Other Business Units

- Regulatory Agencies and Notified Bodies

- Industry peers and associations.

#LI-OPS

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 Location

USA RI - Warwick

Additional Locations

Work Shift

NA (United States of America)
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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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com