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RDQ Continuous Improvement Manager

Company: Smith & Nephew
Location: Memphis
Posted on: June 12, 2021

Job Description:

Role Overview:

The continuous Improvement Manager is responsible for monitoring and standardizing indicators that report project delivery and accuracy. Monitoring incudes direct interaction with local managers and engineers to create and maintain project tracker(s) that reflect owners, tasks, deliverable status and actions. This Manager is responsible for coordinating, facilitating and leading project status review meetings and other meetings as necessary to monitor project deliverables and drive on time delivery and continuous improvement within the Memphis based RDQ team. This manager is responsible for creating and maintaining other indicators as needed to monitor the performance of the local RDQ team, which may include but is not limited to cross training, responses to internal and external audits, quality system development and improvement status. Indicators are reported out on a reoccurring and consistence schedule to Leadership team(s). The Continuous Improvement Manager manages the implementation of corrective actions, preventative actions and continuous improvement activities as needed to drive improvements within the local RDQ team and support functions. The Manger will ensure that the Quality System documents needed for the group are released via the local PLM system by working with RDQ staff. This includes monitoring the needs, status and assisting the core RDQ team with engineering change notices, engineering change requests and training.

The Continuous Improvement Manager will work directly with RDQ managers to ensure that new hires and contractors are on boarded, off boarded according to internal procedures. On boarding activities include but are not limited to following internal policies and practices when ordering equipment, monitoring delivery of equipment and reporting on training status and cross training needs.

The Continuous Improvement Manager is responsible for proactively working internally to align on international standards, ASTM and other applicable standards that apply to product being distributed within the EU and ensuring that design history files and technical files are updated to reflect full or partial compliance alone with testing evidence to support the compliance level.

Please include specific internal and external relationships, product focus (if any), regulatory requirements, etc.

Locally this position will have daily interactions with the core RDQ team. Periodic and ongoing interactions will occur with a larger group including but not limited to Packaging, Clinical, Regulatory, Quality, Product Development, Biocompatibility, Microbiology, Operations, Development and Research.

This role focuses on product that is distributed into the European Union and ensures that the design history files for these products are compliant to Regulation (EU) 2017/745 (EUMDR) and internal policies, procedures and specifications. The products are classified as Orthopaedic devices including implants and instruments. These devices are used to reconstruct hips, knees and utilized during the repair of the anatomy due to traumatic events. While product focus is limited to the EU, the core quality system is implemented to comply with a larger geographical area, thus compliance to 21 CFR, Part 820 and other compliance regulations are required.

Responsibilities:

  • Monitoring and assisting with the on boarding/off boarding of employees and contractors
  • Assist with Quality System development by tracking requirements and status of meeting requirements. Assist with releasing documents in the PLM system by reviewing and formatting documents, proessing engineering change notices/orders.
  • Attending, leading and preparing for meeting, maintaining indicators, issuing reports
  • Standards management
  • Corrective and preventative actions and continuous improvement
  • Training

Location:

Cordova, TN - Goodlett Farms

Education: Bachelor's Degree in Mechanical, Biomedical, Quality Engineering or equivalent engineering degree

Licenses/ Certifications: ASQ certified Quality Manager, Biomedical engineer, preferred

Experience:

  • 10 + years in medical device industry
  • 2 plus years working on cross functional team
  • 5+ years working directly with design control including PMS data analysis, design inputs/outputs, design verification/validation, risk mitigation and quality system development and implementation based on compliance to 21 CFR part 820 and ISO 13485
  • 3+ years of project management, process improvement using lean sigma tools, trouble shooting, root cause analysis, and people management
  • Working/testing knowledge of ASTM, ISO and other standard applicable to orthopedic devices.

Competences:

  • Knowledge of design controls including CFR 820, ISO 13485, ISO 14971
  • Knowledge of EUMDR 2017/745
  • Statistical Analysis; lean sigma tool applications, corrective and preventative action, continuous improvement, root cause analysis, problem solving
  • People and Project management; leading multiple functional groups; facilitation; coaching; facilitation
  • Excellent interpersonal skills, and communication skills both written & verbal
  • Strong team player and contributor
  • "Hands-on" approach
  • Microsoft office with ability to manage data using Excel pivot tables and Power BI, Microsoft Project

Physical Demands:

  • Ability to sit for extended periods of time
  • Ability to lift up to 30 lbs occasionally

Travel Requirements: <10%

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Veterans are strongly encouraged to apply.

Keywords: Smith & Nephew, Memphis , RDQ Continuous Improvement Manager, Other , Memphis, Tennessee

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