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Role Summary                                                          

Reporting to the Senior Manager Quality & Compliance - Country Business & Product Quality Head (US) , the Waterpik Manager, Product Quality is the technical expert in regulatory requirements, standards and best practices in one of more regulatory classification areas. This position is responsible for quality oversight of new product launches, and product changes, ensuring to maintain high quality and applicable compliance.  This position will work closely with R&D, Regulatory, Analytical, Manufacturing Plant Quality and Operations to support the on-time launch of new products and changes and influence these functions in the development of a new product quality plan and change control documents.  The position is also a major contributor to issue resolution utilizing quality engineering skills to ensure on-time commercialization. 

This position, based in Fort Collins, CO leads the Water Pik organization to achieve compliance to the FDA Quality System Regulation (QSR), ISO 13485, MDSAP and/or other quality system standards as required. Functions as the Management Representative for Waterpik. Establishes, maintains and operates systems to measure, assure and improve the local QMS.

Role Accountabilities and Responsibilities                                                 

• Ability to work with all levels of PD, supply chain, technology teams to build relationships across functions
• Strong execution skills
• Ability to think strategically and creatively translate strategy into action
• Demonstrates agility and connectivity across the organization
• Actively builds connections and partnerships with others, internally and externally
• Responsible for Quality and compliance for Water Pik globally, adhering to Church & Dwight corporate policies.
• Responsible for oversight of the Quality Management System for all Water Pik products and services, including report outs of the adequacy and needed changes based on monitoring, metrics. 
• Escalates quality issues to Quality Management for review and appropriate action. 
• Oversees implementation to ensure adherence to new requirements
• Establishes and maintains system for and audit compliance with ISO 13485, MDSAP, ISO 9001, the European Medical Device Regulation, the US Food and Drug Administration current Quality System Regulation, and the Canadian Medical Device Regulations requirements. Completes all documentation, tracking, and follow-up requirements as necessary. Acts as lead auditor during audits.
• Assesses measurability and effect on end user satisfaction of product designs and changes.  Leads investigation of root causes of product-related customer complaints.
• Instructs others in quality and measurement methods.
• Responsible for managing and following quality system procedures.  Leads in procedure development e.g. ISO, FDA, MDSAP, when required.  Ensures product quality and takes appropriate action when non-conformances are identified.  Maintains accurate records.
• Conducts all activities in a fair, ethical manner which is in compliance with all corporate policies.

Operating Knowledge, Skills, and Abilities                                                       

• Standard quality and statistical methods, problem solving methods, process capability methods, sampling methods, fixturing/gauging principles and nondestructive testing methods.
• Requires proven ability in mechanical design evaluation, measurement method and calibration.
• Geometric Dimensioning and Tolerancing methods in design assessment and in measurement method definition desired
• Project and resource management and leadership.
• Creates and leads Teams and Teams of Teams
• Monitors progress by maintaining dialogue on work and results
• Responsible for oversight based on agreed to strategy
• Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
• Ability to prioritize and to handle multiple projects simultaneously.
• Ability to work with all levels of management and to build relationships across disciplines.

Education and Experience                                                          

• University degree in Engineering, Quality or Science.  
• Professional typically with over 12 years technical experience and a demonstrated track record
• Generalist in Consumer products and medical device
• Minimum of 3 years’ of supervisory experience
• Contributions balanced between strategy and functional execution elements; independent; people management
• Consulted internally as an expert in 1 area of functional expertise
• Understanding of FDA, EU, CA medical device regulations, ISO 13485-2016, and MDSAP requirements. 
• Experience in application of Risk Management of medical devices (ISO 14791), Electrical Safety Standards, such as IEC 60335 and 60601, plus EMC Standards such as BS EN IEC 55014
• Basic quality skills, including investigation and root cause analysis, statistics, sampling, test methods.  Advanced quality skills, including experimental design, QFD, COPQ, SPC, control charting, FMEA, and other risk analysis methods desired
• Proven ability in the quality evaluation and controls for electromechanical Medical Devices.
• Proven leadership, team and change management skills.  Experience in project and resource management.

Required Training

Other Qualifications & Physical Requirements                                                        

Some traveling is required in this position both domestically and abroad.

Reporting Relationship: Reports directly to the Senior Manager Quality & Compliance - Country Business & Product Quality Head (US)

Supervisory Duties: Supervises quality engineers

Salary and Benefits

Water Pik, Inc., a partner company of Church & Dwight Company, Inc., supports our employee’s wellbeing and regularly benchmarks with other companies in our industry to offer an extensive Total Reward package for this position.  Salary will be determined by the applicant's education, experience, knowledge, skills, and abilities, as well as internal equity and alignment with market data.

Estimated pay:  $101,600 - $158,800 Annual Salary 

Medical, Dental, Vision Insurance / Healthcare and Dependent Care Flexible Spending / Health Savings Account / Commuter Reimbursement Account

Vacation / Holiday / Sick Time / Pandemic Leave  / Short and Long Term Disability / Life & AD&D / Spouse/Child Optional Life / Supplemental Life & AD&D / Family and Medical Leave / Bereavement

Adoption Assistance / Tuition Reimbursement / Employee Assistance Program / Identity Theft Protection / Critical Illness Insurance

Savings and Profit Sharing Plan / 401(k) Match / Employee Stock Purchase Plan

This information is provided in compliance with the Colorado Equal Pay for Equal Work Act and is the company's good faith and reasonable estimate of the compensation range and benefits offered for this position.  The compensation offered to the successful applicant may vary based on factors including experience, skills, education, location, and other job-related reasons.

This position is expected to close on 12/10/2024.

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Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/