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BD (Becton, Dickinson and Company) Quality Assurance Supervisor in Plainfield, Indiana

Job Description Summary

Primary responsibilities include ensuring the DC maintains a robust, effective Quality Management System that complies with applicable regulations and BD procedures. He/she will provide leadership/supervision for quality processes on the distribution floor (holds, quarantine, damages, scrap, returns, rework, etc.). Operates under direct line supervision to the Manager, Quality Management, US Distribution Centers.

Job Description

RESPONSIBILITIES

  • Oversee and ensure the DC maintains a robust, standardized and effective Quality System which complies with applicable regulatory requirements and Quality Agreements established with business units served.

  • Responsible for leading local site implementation of annual Quality Objectives and Key Business Drivers established for DC operations.

  • Ensure the DCs’ processes, organization, procedures, and activities are adequate to effectively meet the needs of the US Supply Chain and conform to all applicable regulatory requirements and regional standards.

  • Promote a culture of Quality across the local organization that ensures management commitment and understanding of ISO and QSR regulations as they apply to Storage, Distribution and Transportation.

  • Ensure effective implementation and execution of Quality processes conducted under the Quality Systems to accomplish expected requirements and performance.

  • Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business.

  • Lead and/or participate in regularly scheduled Quality Leadership calls to ensure timely implementation of agreed upon actions and facilitate cross site exchange of performance and synergistic activities.

  • Employ and share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts to introduce pro-active improvement and prevent recurrence of issues.

  • Maximize the benefits for the overall system to drive Business, Supply Chain performance and customer satisfaction.

  • Responsible for managing and maintaining an effective local Quality organization including: training, development programs, subject matter expertise, defining and assigning associates’ responsibilities, succession plans, establishing annual IIG’s and evaluating performance.

  • Serves as a Designated Representative to ensure day-to-day operations meet states’ licensing requirements for medical device and/or wholesale drug distribution regulations as applicable.

  • CPR-036 Subject Matter Expert facilitating training to DC personnel and direction where correct identification of damaged product is unclear and/or escalation to the business is required for final disposition. Partner with the businesses and provide summary input on key packaging and configuration issues in order to maintain document currency to product and customer requirements.

  • Effectively evaluate and provide direction to the DC with inventory that has suspected damage and is at risk of being scrapped.

  • Manage the non-conformance process (Quality Notification/QN), collaborate on issues to provide detailed information to source plants, vendors, or carriers to determine root cause. Partner with and/or review Operation’s investigations and effective corrective actions to drive solutions that reduce damage and risk in future shipments.

  • Oversee and monitor the scrap process to ensure compliance to procedure, timelines, and regulatory requirement (Hazwaste, etc.). Facilitate the escalation process with businesses where disposition of inventory identified for scrapping is not meeting established timelines.

  • Facilitate the escalation process with the Social Investing group as applicable where disposition of inventory identified for donation to charitable organizations is not meeting established timelines.

  • Subject Matter Expert for DC Quality Non-Conforming processes (Hold, Quarantine, Damages, Rework, Returns, Temperature Control, Etc.) - facilitating training, coaching and direction. Ensures compliance to standardized processes.

  • Designated business unit Quality representative for facilitation and supervision of remediation/rework activities with DC personnel. Provides on-site training on behalf of the business units on rework protocols when required.

  • Collaborate with Transportation on carrier related issues and driving claims to resolution where escalation is needed. Also, assist Supply Chain and partner with BD businesses on carrier related issues where root cause analysis and corrective actions are initiated to improve carrier performance.

  • Partner with Operations and Supply Chain Relations on customer related issues and driving claims to resolution where escalation is needed.

  • Conduct and participate in audits as required in compliance with regulatory requirements, e.g. ISO 13485, 21 CFR 820.

POSITION REQUIREMENTS

EXPERIENCE:

  • Minimum of 3 years supervisory experience.

  • Experience in Supply Chain and/or Distribution Center Operations preferred.

  • Minimum of 3 years knowledge and experience in a regulated environment, ideally in the medical device and/or pharmaceutical industry.

  • Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820 preferred.

COMPETENCIES:

  • Computer skills (Excel, Word, Power Point, etc.)

  • Process oriented, Continuous Improvement Experience

  • Strong people leadership including: developing, coaching, listening, collaborating, and delegating

  • Excellent organizational, analytical and process efficiency skills

  • Strong interpersonal and written communication skills

  • Project leadership

  • Initiative and drive for results

EDUCATION:

  • BS Degree in Quality Engineering preferred or related discipline, or equivalent work experience plus 3 years supervisory experience in a quality capacity OR Associates degree plus 5 years supervisory experience in a quality capacity OR high school diploma plus 8 years supervisory experience in a quality capacity, plus quality/supply chain certifications.

CERTIFICATIONS:

• ISO 13485 and 21 CFR 820 Lead Auditor certified preferred

Physical Demands

The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions (Per the Americans with Disabilities Act of 1990). While performing this job, the employee is regularly exposed to episodes of walking, standing, stooping, kneeling, balancing, crouching, reaching, pushing/pulling, grasping, hearing, twisting, lifting, frequent use of hand to finger, handle, feel, pick or type which can include repetitive motion of the wrists, hands or fingers. The associate may occasionally be required to climb. The job may require lifting over 50lbs in some areas but not all. The noise level in the work environment is moderate to loud. The position will almost always have exposure to work near moving mechanical equipment, exposure to precarious situations and potential temperature excursions. Occasionally the position will have exposure to fumes/airborne particles. This position requires a pre-employment physical exam.

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.

#LI-PRO

Primary Work Location

USA IN - Plainfield

Additional Locations

Work Shift

US BD 1st Shift 7am-330pm (United States of America)

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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