Sr. Manager, Quality at Sunstar Americas, Inc.

At Sunstar Americas, Inc., we firmly believe that our people are the foundation of our success. We foster a collaborative, innovative, and agile culture that ensures we deliver high-quality, innovative products to consumers and oral care professionals. Our team-oriented approach encourages creative thinking and nurtures a positive work environment and productive relationships. With dedication, hard work, and a shared vision, we can continue to make SAI a leader in our industry.

Join us and become part of our global team, where together, we can achieve success and contribute to a better future.

Position Summary:

Provides leadership for the Quality Assurance and Quality Control functions.  Manages all product testing resources, including physical, analytical and microbiological testing laboratories (inclusive of contact laboratory activities, as applicable), staff and equipment. Develops and maintains corporate policies, quality management system procedures and quality plans to ensure that all quality and regulatory requirements are met. Leads Quality department efforts by providing actionable Quality data and information to the middle- and executive-management, and by influencing decision-making on project priorities to promote the achievement of Corporate Quality improvement objectives and customer satisfaction goals. Applies problem-solving, team facilitation, and management skills to plan and execute quality improvement projects.  Ensures the development of Quality standards, test methods, qualification and validation protocols, and reporting systems to achieve the timely introduction of safe, effective and reliable new products with right-first-time quality. Coordinates with SSSA/SESA, SSJ and the external corporate entities to communicate and resolve global issues involving SAI products. Summarizes and reports quality progress to all Operational areas to ensure that top issues are communicated, and CAPA actions are implemented.

Applies critical and risk-based thinking and quality decisions within all review forums.

Essential Job Functions:

• Manage the QA/QC team (Incoming Quality Assurance, Manufacturing Quality Assurance, and Quality Control (Analytical and Microbiology laboratories, as applicable)) including performance reviews, task management and resource allocation.
• Plan, lead, organize, monitor and improve departmental
• Develop, monitor, and present management review metrics for the area of responsibility.
• Investigate and oversee CAPA and change control projects as required to ensure continuous quality improvement.
• Provide for the training and development of departmental employees to ensure that the appropriate skills are mastered, and performance is optimized.
• Develop quality plans for all incoming materials, finished goods, and in-process inspections. Schedule resources to execute the quality plans effectively, and without interruption to
• Support contract manufacturers review and approval of executed batch records and perform Quality disposition
• Support SAI’s Quality Management Systems by leading compliance initiatives, critical and risk-based thinking, resource analysis and allocation, promoting ownership and accountability.
• Lead six sigma projects when assigned by Management.
• Review inspection and testing results and initiate corrective actions. Ensure the appropriate disposition of all non-conforming
• Summarize quality information, and provide weekly and monthly Quality Reports to Operations, and to other functions as needed. Organize and conduct weekly and monthly meetings with Operations staff to share quality information and to initiate corrective
• Establish and maintain quality systems that meet FDA Medical Device and Pharmaceutical Regulations and ISO 13485 standards.
• Provide laboratory testing and reporting services in support of manufacturing and supplier process validations as well as design development and design
• Lead Operations’ efforts to continually improve process reliability and product quality. Provide training on quality techniques and product quality indicators to Operations
• Participate in new product process design FMEA.
• Review, verify and approve product
• Other duties as assigned by Quality Management.

Education

• Bachelor of Science degree in a scientific or technical field preferred.

Knowledge/Experience

• 10 years Quality Assurance experience in a medical device/ pharmaceutical manufacturing environment, and least 7 years in a management role.
• ASQ Certification (CQE, CQM) or Six-Sigma certification is preferred.
• Experience in developing SOPs and test methods, drafting product and process validation protocols, and reporting scientific test results in a professional manner.
• Experience in managing a physical, chemical or microbiological testing laboratory.
• Comprehensive knowledge of ISO 13485 and FDA Medical Device and Pharmaceutical GMP standards and
• Strong knowledge and application of problem and cause analysis tools and techniques including risk management principles.
• Ability to establish a budget and monitor and control expenditures.

Skills

• Demonstrated proficiency in the use of databases, spreadsheets, and statistical
• Excellent computer skills. Experience with MS Office applications
• Excellent written, presentation, and verbal communication skills
• Team facilitation skills, and the ability to communicate effectively with all levels within the organization
• Coaching, mentoring, and training skills

Abilities

• Management: the ability to organize and manage multiple priorities which meet compliance requirements and expectation, timeliness, and thoroughness.
• Ability to communicate, interact and work effectively with people from diverse ethnic and educational backgrounds, as well as across all levels of the organization.
• Planning and anticipation: forward thinking with the ability to plan 3-6-12 month time span applying excellent project management skills, communication and progress reporting, course correction and escalation.
• Ability to communicate critical issues to management in a timely manner.
• Manage and resolve conflicts in a positive manner and create a positive work environment

What Makes Sunstar Special is:

• A business focused on health and wellness of people around the world
• High Quality Products
• Beautiful state-of-the-art facility
• Diversity and Inclusion
• Corporate Social Responsibility Program and partnership with charitable organization
• Strong value placed on company culture
• Excellent, comprehensive insurance coverage that includes Medical, Vision, and Dental benefits. 
• Opportunities for career growth and advancement
• Employee discount on Sunstar products
• 401K retirement plan with employer match (Pretax and Roth options)
• 401K profit sharing contribution based on company performance.
• Paid holidays and generous paid time off. Pet, Legal and Identity Theft Insurance Plans
• Competitive bonus
• On-site café
• On Site Fitness Center
• Corporate Perks Discount Program (Auto, Retail, Electronics, Entertainment, Computers, Personal Vacations, Cell Phones, Movie Tickets, Eating Out and Much More)
• Holiday Lunches
• Beautifully maintained walking trails
• Hybrid Schedule (certain departments)
• Numerous employee appreciation events throughout the year.
• Recognition and Rewards Programs
• Anniversary, Birthday and New Hire Announcements

 If you’d enjoy a career helping others attain overall health through oral health, consider joining the Sunstar Americas, Inc. team.

The employer is subject to certain governmental record keeping and reporting requirements for the administration of civil rights laws and regulations. In order to comply with these laws, the employer invites employees to voluntarily self-identify their gender, and race or ethnicity. Completion of this data is voluntary and will not affect your opportunity for employment or terms or conditions of employment. Information collected will be used for EEO-1 reporting purposes only and will be kept separate from all other personnel records, only accessed by Authorized Users. Information collected will be kept confidential and will only be used in accordance with the provisions of applicable laws, including those that require the information to be summarized and reported to the federal government. When reported, data will not identify any specific individual. 

The pay range for this position of Sr. Manager, Quality is $119,893 - $179,840. However, base pay offered may vary depending on skills, experience, job-related knowledge and location. This position is also eligible for an annual bonus as part of total compensation.