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Quality Assurance Manager - Sarasota, FL (Finance)

Company: Dentsply Sirona
Location: Sarasota
Posted on: May 3, 2021

Job Description:

Quality Assurance Manager - Sarasota, FL (Finance)

Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares are listed in the United States on NASDAQ under the symbol XRAY.

Bringing out the best in people

As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us.

Working at Dentsply Sirona you are able to:

Develop faster - with our commitment to the best professional development.

Perform better - as part of a high-performance, empowering culture.

Shape an industry - with a market leader that continues to drive innovation.

Make a difference -by helping improve oral health worldwide.

Position Summary

  • The primary job responsibility (Scope) for the Quality Assurance Manager is overseeing the day-to-day functions of the Dentsply Sirona Orthodontics Quality Management System (QMS) at the Sarasota, FL location.
  • In addition, the manager will provide input into QMS processes affecting other locations within the scope of the Dentsply Sirona Orthodontics Quality Management System.
  • This job function directly affects product quality.

Key Responsiblities

  • Responsible for administering programs and procedures for quality/regulatory compliance while maintaining and/or supporting identified routine quality systems and processes.
  • Manages the Sarasota, FL location Quality Assurance/Quality Control staff including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning, and fostering a positive working environment.
  • Management oversite of the Dentsply Sirona Orthodontics Quality Management Systems Product Realization processes, including but not limited to Change Control, Calibration, Monitoring & Measurement of Product, Supplier Control, Product Complaint Investigations, Process Verification & Validation, and Measurement, Analysis, and Improvement processes, including but not limited to Control of Non-conforming Product, CAPA, Internal Audit and Rework.
  • Acts as the primary Quality representative for transfer projects into the Sarasota, FL location with full technical responsibility for interpreting, organizing, executing, and coordinating successful transfers into manufacturing. This includes but is not limited to development of associated Quality Plans, determination of resource needs, quality documentation, verification/validation requirements, and oversite to maintain the current QMS.
  • Plans, and manages projects of major scope and significance to the company.
  • This position is directly responsible for developing and overseeing the implementation of the strategic and tactical plans that meet the businesses objectives by maintaining and developing an effective Quality Management System and developing solutions to quality-related problems identified through quality system data collection and analysis while supporting overall business needs.
  • Works as a strategic minded manager to proactively and reactively develop and implement practical, timely, and effective business solutions to quality issues.
  • Acts as an internal champion for quality initiatives aimed at improving business systems and compliance.
  • Hands-on functional leader who collaborates cross functionally to ensure compliance with ISO 13485:2016; MDSAP; 21 CFR 820, EU MDD and MDR and other requisite regulatory requirements.
  • Leads and/or oversees quality improvement initiatives associated with continuous/cost improvements.
  • Active member of the product development team to ensure production specifications are transferable to manufacturing processes able to meet a validated state.
  • Utilizes Quality Assurance tools and methods for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.
  • Utilizes Quality Engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
  • Reviews/analyzes the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  • Active member of benchmarking activities within the Orthodontic group to develop more effective methods for improving quality.
  • Establishes metrics that are leading and lagging indicators of quality.
  • Champions compliance to applicable worldwide regulations and standards including providing support during internal and external audits/inspections.
  • Ensures appropriate application of process validation and process control activities.
  • Oversees the development of measurement systems/capabilities, test method qualifications, destructive tests, and non-destructive tests.
  • Oversees the development of control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
  • Ensures collection of data and executes/conducts various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support. This includes but is not limited to development, of both standard and non-standard sampling plans
  • Develops, interprets and implements appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Oversees the documentation, review and approval of investigations of non-conformances, CAPAs and customer complaints as required.
  • Escalates and advises top management on technical matters of potential quality issues and/or delays as appropriate, fostering timely resolution.
  • Represents management throughout all areas of the business to ensure a team-based approach to effective quality solutions.
  • Develops/revises applicable standard operational procedures, work instructions, forms etc. to meet corporate, and worldwide regulatory requirements and optimize the quality management system.
  • Documents quality data using good documentation practices both manually and electronically, ensuring all quality data is in a retrievable state to support continuous improvement activities.
  • Ensures adherence to departmental approved budgets.
  • Conducts conformity assessment audits of policies, procedures, and quality systems to identify non-conformities and ensure prompt and effective corrective actions are accomplished.
  • Oversees Supplier Certification Program as it relates to Quality. To include ensuring effective supplier control methods are in place, tracking/reporting supplier performance and issuance of Supplier Corrective Action (SCAR) as needed.
  • Provides input in developing internal quality metrics and tracking systems, evaluates data and trends and develop actions via the CAPA process reporting findings through PSC and Management Reviews.
  • Fosters a positive, productive relationship with local and Corporate stakeholders, including but not limited to the Regulatory Compliance, Research & Development, Production and Supply Chain teams.
  • Approves documents, processes, and product designs within the quality system.
  • Supports the development of quality engineering, quality compliance, quality leadership talents with the right skills sets for new product introductions, and product life cycle management.
  • Ensures on time completion of all training, CAPA, Internal Audits and other related Quality Management System based activities associated with themselves and their team.
  • Responsible for training, evaluation, and development of direct staff to facilitate the attainment of company quality and regulatory strategies and objectives. In addition, assists in the training of cross functional personnel, with respect to quality issues as required.
  • Develops team culture to provide an optimum environment for employees' growth and contribution.
  • Establishes individual performance objectives and reviews performance against goals. Provides counseling.
  • Plans and implements programs for the timely development and progression of their direct reports.
  • Plans and recommends salary increases, promotions, as appropriate. Handles discipline and documentation steps in problem employee situations.
  • Provides ongoing feedback and mentoring to direct reports and completes annual performance reviews for the Quality Assurance staff.
  • Responsible designee for the Quality/Regulatory Compliance Director.
  • Prepares compliance reports to present to management as required; and
  • Other duties as directed and/or approved by QA/RC Director.

Key Skills & Experiences

  • Bachelor's degree in a scientific discipline, engineering degree preferred.
  • Quality Manager Certification and/or Certified Quality System Auditor is a plus.
  • Minimum of 5 years' management experience in Medical Device, Pharma or Biomed or other regulated industry
  • Excellent understanding of FDA Good Manufacturing Practices and/or ISO Quality Management System Requirements.
  • Excellent problem solving, time management, organizational, and interpersonal skills
  • Strong process validation knowledge and background.
  • Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate quality risks.
  • Highly motivated self-starter with the ability to function in a fast-paced, team-oriented environment with minimal supervision.
  • Ability to deal with a variety of variables in situations where limited information exists.
  • Ability to manage conflict.
  • Ability to set team and individual goals.
  • Excellent communication and influence skills with the ability to work interactively with off-site resources.
  • Ability to articulate thoughts and ideas effectively through both written and oral communication.
  • Proficient in Microsoft Office software, including Outlook, Work, Excel, and PowerPoint, as applicable.
  • Microsoft Dynamics AX and SmartSolve knowledge preferred.
  • Ability to perform effective investigational and root cause activities.
  • Ability to multitask and prioritize practices to meet defined timeliness requirements.
  • Must be detailed oriented and well organized.
  • Proficient in reading, writing and communicating in English.
  • Ability to speak Spanish a plus

DentsplySirona is an Equal Opportunity/ Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in DentsplySirona.

If you need assistance with completing the online application due to a disability, please send an accommodation request to . Please be sure to include "Accommodation Request" in the subject.

Keywords: Dentsply Sirona, Sarasota , Quality Assurance Manager - Sarasota, FL (Finance), Other , Sarasota, Florida

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