Quality Assurance Manager - Sarasota, FL (Finance)
Company: Dentsply Sirona
Posted on: May 3, 2021
Quality Assurance Manager - Sarasota, FL
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
Perform better - as part of a high-performance,
Shape an industry - with a market leader that
continues to drive innovation.
Make a difference -by helping improve oral health
- 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.
- 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
- Plans, and manages projects of major scope and significance to
- 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
- 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
- Champions compliance to applicable worldwide regulations and
standards including providing support during internal and external
- 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
- Oversees the development of control plans consistent with
product classification, potential defect types, defect frequency,
severity, patient risk, process capability, process controls,
- 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
- Develops, interprets and implements appropriate process
monitoring and control methods consistent with the level of
- Oversees the documentation, review and approval of
investigations of non-conformances, CAPAs and customer complaints
- Escalates and advises top management on technical matters of
potential quality issues and/or delays as appropriate, fostering
- 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
- Documents quality data using good documentation practices both
manually and electronically, ensuring all quality data is in a
retrievable state to support continuous improvement
- 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
- Fosters a positive, productive relationship with local and
Corporate stakeholders, including but not limited to the Regulatory
Compliance, Research & Development, Production and Supply Chain
- Approves documents, processes, and product designs within the
- Supports the development of quality engineering, quality
compliance, quality leadership talents with the right skills sets
for new product introductions, and product life cycle
- 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
- Provides ongoing feedback and mentoring to direct reports and
completes annual performance reviews for the Quality Assurance
- Responsible designee for the Quality/Regulatory Compliance
- Prepares compliance reports to present to management as
- Other duties as directed and/or approved by QA/RC
Key Skills & Experiences
- Bachelor's degree in a scientific discipline, engineering
- 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
- Strong process validation knowledge and background.
- Ability to assess project risks, and where appropriate,
recommend contingency plans and strategies to mitigate quality
- Highly motivated self-starter with the ability to function in a
fast-paced, team-oriented environment with minimal
- 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
- Ability to multitask and prioritize practices to meet defined
- Must be detailed oriented and well organized.
- Proficient in reading, writing and communicating in
- 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
email@example.com . 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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