Quality Specialist III

Position Summary

Growth, Culture, People and Careers: this is the Teleflex Advantage. The Quality Specialist provides support and leadership for quality related processes, including but not limited to the Global Ship Hold process, audit process management support and quality systems meetings and forums, and maintains control of the NADC Quality Hold Cage. Additionally, the Quality Specialist will monitor and analyze quality restricted material within the distribution center to perform trend analysis and opportunities for improvements.  

Principal Responsibilities

•    Quality system compliance to ISO 13485, ISO 9001, 21CFR 820 and Medical Devices Regulations 
•    Governance and management of the Global Ship Hold process, SME for Ship Hold process, including but not limited to:
o    Manage initiating ship holds on behalf of non-Agile PLM sites.
o    Manage completion of stock assessment/verification (Physical verification of impacted stock) in collaboration with DC operations. 
o    Manage and submit stock assessment quantities in Agile.
o    Manage and oversee the completion of any local restriction activities in relation to ship holds. 
o    Manage ship hold disposition confirmation activities.
o    Manage, verify and resolve discrepancies of product quantities at all stages of the ship hold process.
o    Incorporate DC Finance, DC Demand Planning, etc. as applicable in the completion of disposition activities.
o    Manage reconciliation and provide any required documentation to support closure of each phase of the product ship hold and the subsequent closure 3PL/DC.
o    Manage and review ship holds to ensure all ship hold DC tasks have been completed and closed.
o    Managing unauthorized ship hold releases in SAP.
o    Manage completing product batch reports for ship holds in SAP and Agile.
o    Governance of all products contained within the Quality quarantine cage.
o    
•    Responsibility for Administration and oversight of quality systems processes including but not limited to: 
o    Maintain documentation and communications with the Field Corrective Actions (FCA) Team
o    Distribution Center (NADC) audit process Internal Audit support, 
o    ISO / Regulatory authority support 
•    Lead / support internal audits 
•    ISO / FDA / etc. Regulatory authority support 
•    Assist the NADC with resolution of local quality issues 
•    Support QRB (Quality Review Processes) & MRB (Material Review Board) processes 
•    Manage and complete sample requests for external clients.
•    Manage with all Nonconformance sort activities.
•    Manage restricting and quarantining nonconforming products.
•    Verifying and updating essential product information in SAP and Blue Yonder.
•    Providing Global Operations with visibility reports in relation open product ship holds
•    Provide KPI metric reports periodically and on request.
•    Own and drive metrics to become a key player in the development of processes to enable and support both the gathering and improving of metrics associated with quality processes. Analyze and identify trends from quality data and develop proactive measures in support of continuous improvement. 
•    Provide KPI metric reports periodically and on request.
•    Investigate and provide required documentation upon request from the Field Corrective Action Team.
•    Manage and maintain Recall/Scrap trailer logs for product disposal.
•    Manage the NADC Quality Cage, including maintaining accurate inventory records, scrap activities, and all associated documentation.
•    All other duties as assigned.

Education / Experience Requirements

•    3+ years' experience working within quality in a medical device environment or similar type of role is required/
•    Bachelor’s degree in engineering, business, logistics or operations is preferred 
•    Experience with Blue Yonder WMS is a plus.
•    Experience with SAP applications is a plus.
•    Excellent computer skills (MS Word, Excel, and PowerPoint) is required.
•    Internal Auditor qualification – an advantage 
•    Excellent technical writing skills – essential 
•    Attention to detail and accuracy – essential 
•    Problem solving skills for developing creative solutions and meeting objectives are required. 
•    Certifications (e.g. CQIA, CQPA, Six Sigma, etc.) preferred.

Specialized Skills / Other Requirements

•    Strong communication skills, both oral and written with the ability to prioritize and meet deadlines for multiple projects. 
•    Ability to work well in a fast-paced environment under pressure and maintain positive, enthusiastic attitude.
•    Eagerness to learn and expand responsibilities.
•    Ability to work effectively in a team environment and build strong working relationships.
•    Experience with systematic project management and problem-solving methodologies is preferred. 
•    Statistical analysis techniques with excellent verbal, written, and presentation skills.

Key Relationships/ Interfaces

•    NADC Ops and QA leaders 
•    Global QA Team 
•    Global Operations and Logistics 
•    Global Manufacturing Team
•    Customer Service 

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