Sr. Manager, Product Quality

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Role Summary

• Reporting to the North America Business & Product Quality Head, the U.S. Business & Product Quality Head is responsible for contributing to the strategic direction, development and implementation of quality & compliance policies, processes and programs for the U.S. business. The position will work closely with senior management of the U.S. business to ensure appropriate communication, escalation, and prioritization of issues. This position is responsible for setting the direction and influencing Marketing, Sales, Regulatory, Legal, Supply Chain and R&D leaders to support identified improvements, as well as culture changes, to ensure an appropriate level of quality and compliance risk within each SBU. This role serves as the Management representative for Home Office, as applicable.

Strategy and Functional Expertise

• Knowledge of policies, procedures and metrics
• Standard computer based software knowledge
• Keeps accurate documentation and submits detailed reports to appropriate executives
• Skills in data analysis to report and present effectiveness of business processes
• High attention to detail, organization and accuracy
• Math abilities and working knowledge of data analysis/statistical methods
• Contributes to policy, strategy implementation, and execution of relevant policies and procedures across manufacturing sites
• Ability to think strategically and creatively translate strategy into action

Leadership and Influence

• Well organized and demonstrates forward leaning and high initiative
• Ability to influence cross functionally to deliver against business goals and objectives
• Leads and directs strategic programs focused on meeting regulatory company requirements
• Manages and develops other members of the team
• Mentors others in technical areas of expertise
• Demonstrates broad business orientation
• Shows personal commitment to the vision and creates energy and optimism
• Develops others through coaching, feedback, exposure and stretch assignments
• Promotes a culture of collaboration and teamwork across organizational boundaries
• Demonstrates strong leadership skills
• Keeps current on trends in the marketplace, with the competition, and in the organization
• Empowers others and creates a climate where people are motivated to do their best
• Places a high priority on talent development and succession planning
• Translates the vision and strategy

Program Development/Program Management

• Tests, confirms and/or improves processes to ensure they are in control and being followed
• Monitors project progress and sets deadlines and budgets
• Solves issues quickly and efficiently
• Ensures Stakeholder Satisfaction
• Delivers project tasks on time
• Works cross-functionally to identify and communicate regulatory requirements
• Works cross-functionally to influence others to align with new requirements
• Oversees implementation to ensure adherence to new requirements
• Set requirements for suppliers and monitor their compliance
• Oversee all product development procedures to identify deviations from quality standards
• Monitors spend and identifies additional project needs
• Evaluates Project Performance
• Ability to prioritize and handle multiple projects simultaneously
• Communicates and engages appropriately with vendors/suppliers
• Conducts sensitive conversations in a confidential manner with vendors/suppliers
• Maintains sensitivity of communication with internal and external entities (e.g. stakeholders, vendors, suppliers)
• Monitors progress by maintaining dialogue on work and results
• Makes good and timely decisions that keep the organization moving forward
• Provides clear direction, removes obstacles, and holds self and others accountable
• Creates and leads Teams and Teams of Teams
• Responsible for oversight based on agreed to strategy

Impact/Reach

• Strong execution skills
• Demonstrates agility and connectivity across the organization
• Actively builds connections and partnerships with others, internally and externally
• Ability to work with all levels of PD, supply chain, technology teams to build relationships across functions
• Strong communications and the ability to adjust content and delivery to meet the needs of the audience
• Creates and captures value for R&D and the business through contributions
• Participates in due diligence assessment and integration of new acquisitions

Education and Experience

• University’s degree from an accredited institution in a related field
• Professional typically with over 15+ years technical experience and a demonstrated track record
• Generalist in at least 3 areas: Consumer products, electronic device, medical device, food, dietary supplements or pharmaceutical
• Preferred 5 years’ of supervisory experience
• Contributions balanced between strategy and functional execution elements; independent; people management
• Consulted internally as an expert in at least 2 areas of functional expertise

Skills and Competencies

• Ability to develop and implement complex global quality strategies.
• Practical understanding, interpretation, and application of ISO13485, MDSAP.
• 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
• 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 think strategically and creatively and to translate strategy into action plans.
• Ability to prioritize and to handle multiple projects simultaneously.
• Demonstrated talent management experience with developing talent for the future.
• Ability to work with all levels of management and to build relationships across disciplines.
• Excellent influence, persuasion, communication, and presentation skills.