BD (Becton, Dickinson and Company) Quality Specialist 1, Dist. in Four Oaks, North Carolina
Job Description SummaryAs directed by the Quality Manager, Distribution Operations, the Quality Specialist 1 is responsible for executing Quality responsibilities and capturing accurate records of the Rebox process.
Primary Responsibilities and Duties
Responsible for appropriate classification of products eligible for re-box.
Responsible for selecting and printing accurate replacement labels and cases that meet original product specifications.
Responsible for re-boxing inner contents using original configurations.
Capture accurate records and label samples of the re-box process.
Follows applicable corporate company procedures and may make updates to procedures and policies.
Accountable for quality execution of the re-box / re-work process, and ensuring the compliance within quality assurance systems.
Applicable procedures and training.
Process records, line clearance reviews and approval.
Printing of required labels.
Collaborate with FedEx re-box associate for appropriate classification of products eligible for re-box.
Train and mentor functions as the SME for the quality processes above as well as applicable requirements from ISO 13485 and 21 CFR 820 when appropriate.
Other duties and responsibilities as assigned.
Strategic Orientatio n:
Specific scope of responsibilities is to be based on the specific role.
Ensures the accurate and actionable records for the making of decisions.
Ensures re-box process follows applicable released procedures.
Examples of internal (BD) contacts:
Degree of Accountability :
Making key decisions that affect business performanceand examples .
Provides Erroneous decisions or recommendations which would typically result in failure to achieve critical organizational / functional objectives.
Failure to maintain compliant quality systems that could result in audit findings or breach of Quality agreement with regional business units.
Failure to follow and apply documented quality control which could result in compliance and potential market actions including product recall.
Failure to follow and apply documented quality control which could result in revenue loss associated with market actions including product recall.
KSA Requirements (Knowledge, Skills, and Abilities)
Working knowledge and application of ISO 13485 and 21 CFR 820 (Preferred)
Excellent communication, problem solving, attention to detail, organizational and interpersonal skills are essential.
Associate degree (Preferred) in related discipline or a combination of equivalent education and experience.
Certifications (if applicable)
A minimum of 2 years relevant experience or a combination of equivalent education and relevant experience in medical device and/or pharmaceutical regulated industry within quality, supply chain and/or distribution center operations.
Computer skills (Excel, Word, Power Point, etc.)
Requires minimal supervision and able to follow established procedures as directed.
Demonstrated abilityto work in teams to obtain results is required.
Primary Work LocationUSA NC - Four Oaks
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.