Sr. Quality Manager- Production & Process Controls

Antioch TN SmileDirectClub

US-TN-Antioch

Job ID: 2019-8635
Category: Production & Manufacturing


Job Type

Full-Time

Overview

Sr. Quality Manager – Production and Process Controls

We’re Access Dental Lab, and we believe everyone deserves a smile they’ll love. We also believe that you deserve a job you’ll love. Good thing you found us, and we found you. At Access Dental Lab, we’re all about empowering transformation. We want people to become more confident in how they look, how they feel, and how they think. So we’re spreading smiles and positivity all over the country. It’s no small task. That’s why we’re looking for energetic, passionate, and confident team members who can help turn frowns, in to life-changing grins. Are you up for it?

Our Orthodontic Production facility has an immediate need for Sr. Quality Manager of Production and Process Controls.

Responsibilities

  • Manage and lead the quality operations department and all aspects of the personnel process such as hiring, onboarding, mentoring, coaching, defining and setting annual objectives, performance management and employee development.
  • Resource management and planning of department personnel in alignment with production forecasts and business needs to include departmental costs and financial reviews.
  • Provide QA oversite, leadership and technical expertise across all aspects of product manufacturing from raw materials, warehouse activities, quality control, engineering, manufacturing, design transfer and operations support.
  • Monitor and oversee record review process to include the driving of quality record completion i.e. change controls, deviations, non-conformance investigations and CAPA.
  • Support post release safety risk management(per ISO 14971) and act in a coaching capacity for process failure mode and effects analysis (PFMEA).
  • Create and generate a departmental culture of Quality on the Floor and drive quality culture initiatives i.e “win as team”, transparent communication, process focused, information accessibility, no success or failures only learnings.
  • Prepare quality documents such as SOP’s, technical documents, continuous improvement proposals, change controls, complaint investigations and investigation summaries.
  • Manage the completion of GMP documentation in timely fashion to ensure compliant and efficient service to both internal and external stake holders.
  • Ensure new products, processes and equipment are effectively implemented and presented to key stake holders. Act as QA Ops representative during regulatory inspections as well as internal audits.
  • Establish, monitor and own departmental KPI’s, plans, goals and objectives. Drive timely completion of departmental KPI’s and present metrics in weekly operations meetings.
  • Collaborate with cross functional team leaders to facilitate timely completion of operations related goals and objectives.
  • Develop, lead and support continuous improvement projects within and across varying departments in order drive timely and effective improvements business wide.
  • Open and clear communication with Sr. leadership team on encountered issues and challenges preventing successful completion of business goals and objectives.
  • Ensure department compliance with GMP, Data Integrity and Good Documentation Practices (GDP) in accordance with applicable quality documents, SOP’s and standards

Qualifications

It will really make us smile if you have

  • Natural leader, seeking out better ways to ensure Company and team’s success.
  • Experience training new and existing team members in processes, systems, target goals, and quality of the product.
  • A flexible personality that can thrive in the fast-paced environment of a rapidly growing company.
  • Excellent teamwork and time management skills.
  • Excellent written and verbal communication skills.
  • Bachelor’s degree in engineering science or other technical discipline and a minimum of 7 years experience or 5 years with Masters degree.
  • 3+ years of progressive leadership experience in functional area or related field.
  • Certified Six Sigma Black Belt, CQE or CRE preferred.
  • Working knowledge of industry standards and regulatory requirements (including but not limited to: ISO 13485, ISO 14971, MDD 93/42 EEC, CMDR, PMDA, RDC 59, TGA and 21 CFR Part 820)
  • Demonstrated track record of Regulatory Inspection management.
  • Experience implementing systems that drive compliance with all requirements.

Benefits of joining the club:

• Medical, Dental and Vision Insurance 401K with match

• PTO Aligner and Whitening Benefit

• Collaborative work environment and positive culture

Access Dental Lab manufactures invisible aligners for SmileDirectClub customers. SmileDirectClub was founded on a simple belief: everyone deserves a smile they love. The Company is the first digital brand for straightening your smile, created after the realization that recent trends in 3D printing and telehealth could bring about disruptive change to the invisible aligner market by matching licensed professionals, a quality clear-aligner product, and customers together. By leveraging proprietary, cutting-edge technology, SmileDirectClub, LLC-affiliated dentists are providing greater access of care to consumers who couldn’t otherwise afford orthodontic treatment to get a better smile.

Benefits of Joining the Club

  • Medical, Dental and Vision Insurance
  • 401K with match
  • PTO
  • Aligner and Whitening Benefit
  • Collaborative work environment and positive culture

Company Profile

SmileDirectClub was founded on a simple belief: everyone deserves a smile they love. The Company is the first digital brand for straightening your smile, created after the realization that recent trends in 3D printing and telehealth could bring about disruptive change to the invisible aligner market by matching licensed professionals, a quality clear-aligner product, and customers together. By leveraging proprietary, cutting-edge technology, SmileDirectClub, LLC-affiliated dentists are providing greater access of care to consumers who couldn’t otherwise afford orthodontic treatment to get a better smile.

To apply for this job please visit topspotjobs.com.