Sr. Manager, Quality Engineering

As a member of the Sunstar Group, Sunstar Americas, Inc., a global organization dedicated to improving overall health through oral health worldwide, holds a prominent position in the oral care industry. Formerly known as the John O. Butler Company, we are renowned for our exceptional production and distribution, and high-quality oral care products. With our headquarters in Schaumburg, Illinois, and branches in Canada, Mexico, Colombia, Brazil, and Argentina, as well as distribution partners in Central and South America, we have established ourselves as an industry leader.

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.

Position Summary:

Manage and lead timely, cross functional, and compliant validation activities, product transfer, validation program design and associated risk management including escalation and resource prioritization. Ensure development and maintenance of CPPs, CQAs, VMP, specification changes, process analysis tools and templates. Maintain the site validation program to meet cGXP FDA requirements and expectations including applicable global regulations, standards, and guidance. Support continuous improvement activities, quality system activities and oversite of all validation, qualification, studies, and comparative analysis that demonstrates repeatability and reliability.

Support the efforts of quality assurance, quality control, product development, and production personnel towards effective manufacturing of oral care products at a level of quality consistent with industry standards and customer requirements.

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

Essential Job Functions:

• Manage the QA Engineering team (QA Technicians, Quality Engineers, Validation Engineers) including performance reviews, task management and resource allocation.
• Ensure that the training of all direct reports is up to date, including any change of training assignment or retraining requirement.
• Quality decision maker, coordinator, and/or reviewer/approver in the following forums - Product development, changes, and design review including the comparative analysis.

- Risk control board (RCB)CAPA review board (CRB) including complaint investigations, NCRs, Deviations.

- Material Review Board (MRB)

- Change control review board (CCRB)

- Equipment control definition, calibration, asset management, maintenance, validation and qualification.

-Tech transfer and CMO changes

• Lead Risk Management activities including development and maintenance of risk management files, risk assessments, and FMEAs.
• Review and approve Design and Tech Transfer activities, creation of protocols (IQ, OQ, PQ), test reports, data analysis, verification of risk management plan deliverables.
• Create, monitor, review/approve all validations and qualifications including development of CPP and CQAs as well as maintenance of Master Validation Plan.
• Maintain the current validation program to include: process, cleaning, software, test methods, equipment, facility, utility, instruments, transfer, environmental controls including vendor executed protocols and oversite.
• Develop, monitor, and present management review metrics for the area of responsibility.
• Supports engineering studies, DOEs, process evaluations and user requirement documents.
• Ensure that the First of Code (1st Article) activities are performed per specifications; performs the quality review and approval.
• Summarize test data using complex data evaluation and statistical analysis tools (e.g Minitab)
• Investigate and oversee CAPA and change control projects as required to ensure continuous quality improvement.
• Coordinate technical data analysis and risk assessments to support complaint decisions and post market activities.
• Perform process capability studies, comparative analysis, and gage R&R as needed. Implement proper process monitoring, data integrity controls, metrics, and control limits, including trend analysis and investigations.
• Identify and integrate new external regulatory standards, guidance documents and technical requirements into internal procedures, forms, and templates to ensure compliance to FDA requirements, Health Canada, ANVISA, ISO, and applicable global regulations.
• Ensure that all Standard Test Methods (STM) are current to regulations and standards.
• Support contract manufacturers review and approval including audits and risk assessments.
• 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.
• Other duties as assigned by the Quality Management.

Education

• Technical 4-year degree, preferably Bachelor of Science in Engineering.
• Leadership certification/training.

Knowledge/Experience

• Min 7 years QA Engineering experience in a medical device and drugs manufacturing facility, or equivalent.
• Min 10 years in Quality Assurance field.
• Min 7 years managing a quality function, engineering, or equivalent department.
• Proficient with quality engineering problem solving methods/tools, development, and monitoring of CPPs and CQAs.
• Expert in data analysis, statistical process analysis and controls, process monitoring and performance indicators.
• Strong knowledge and application of FDA and global regulations and standards (including guidance documents), ISO, GAMP, and ASTM applicable standards related to validation and equipment controls.
• Strong knowledge and application of problem and cause analysis tools and techniques including risk management principles.

Skills:

• Demonstrated proficiency in the use of databases, spreadsheets, web-based applications, and statistical software.
• 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
• Time management

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 in a timely manner.
• Manage and resolve conflicts in a positive manner and create a positive work environment

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.

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 2.5% 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