Senior Supplier Quality Engineer

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.

Why Work at Sunstar? Sunstar’s mission is to enhance the health and well-being of people everywhere via its four business areas: mouth and body, health and beauty, healthy home, safety and technology

Position Summary:

The Senior Supplier Quality Engineer is responsible for maintaining and leading the Supplier Qualification activities and managing the supplier management program for the SAI Schaumburg site. This individual must effectively work with quality, regulatory, operations, laboratories, purchasing, engineering, finance, suppliers and CMO’s to ensure that suppliers are appropriately evaluated, monitored, qualified/disqualified and documentation is maintained. The Senior Supplier Quality Engineer ensures effective resolution of supplier issues, failures, changes, transfers/transitions as well as ensures SAI implements appropriate internal controls, monitoring, metrics, risk-mitigations, quality agreements, specifications and purchasing controls which render compliant components, materials, products and services by third parties.

Essential Job Functions:

• Managing and maintaining the SAI Supplier Quality Program and assuring compliance with all applicable global regulatory requirements and standards for vendors, suppliers, service providers, CMOs, OEMs and third parties.
• Provide strategic and risk-based leadership in the execution of Supplier Quality activities ensuring compliance to procedures, specifications and Quality Agreements as well as Purchasing, Distribution, Licensing agreements and contracts in place for SAI products, processes, roles and responsibilities.
• Creating and approving supplier evaluations, supporting documentation, quality agreements, assessment against regulatory requirements/standards, risk assessments and ratings for supplier activities/capabilities, review/approval of Supplier proposals including approval/rejection/restrictions, notice of changes, performance scorecards and Management Review metrics.
• Create and maintain the supplier audit program including performance scorecards, trending, metrics, audit planning, reports, responses and schedules.
• Monitoring and coordinating resolution of failures/actions/changes required for issues and notice of changes from Purchasing, Suppliers/Vendors, Service Providers, Contract Manufacturing Organizations (CMO), and Original Equipment Manufacturers (OEM).
• Applying risk-based strategic planning for SAI related actions, internal mitigations and containment activities, testing and inspection for supplier issues and evaluations, gap assessment results as well as ensuring failures/changes in supplier issues are evaluated, documented and approved in a compliant manner.
• Lead supplier continuous improvement plans and activities based on leading, lagging or failing indicators of performance.
• Initiate, review, approve, lead and manage timely handling of supplier exceptions, deviations, CAPAs, effectiveness verification and changes (new or revised) to minimize impact to production, supply chain, transition, tech transfer or any improvement initiative as well as ensure appropriate handling of any failures/changes with potential impact on product quality, safety, efficacy and impact to the regulatory filing, supplier status, purchase orders or quality agreement.
• Establish and maintain successful cross-functional relations with Design & Development, Engineering, Manufacturing, Operations, Quality Control, Quality Assurance, and Purchasing departments.
• Evaluate, monitor, define effective process monitoring which ensures that the commitments of the Quality Agreements and contracts are being fulfilled and help facilitate resolution in cases when they are not.
• Maintain governing procedures, forms, Approved Supplier List(s) and supplier files.
• Serve as a Subject Matter Expert during Internal and External inspections, audits, assessments, and remediation activities.
• Manage the internal audit program by scheduling and conducting internal audits of each department in the quality system, provides objective assessment of site quality compliance to management, tracks/trends internal quality data relating to quality performance.
• Provides audit support for outside regulatory audits and inspections.

Education

• Bachelor's Degree required, preferably in a Science or Engineering discipline.

Knowledge/Experience

• 5 years experience in the pharma or medical device regulated industry in Quality Assurance, Compliance and Supplier quality related functions.
• 3 years experience in management of cross functional teams in a Quality System, compliance and/or Supplier Quality role.
• Experienced in FDA requirements, regulatory expectations and standards related to Supplier Quality as well as compliance remediation, project management, risk management and gap assessments.

Skills

• Strong leadership skills to motivate and enable cross-functional personnel in meeting objectives, risk-based decision making, timeliness, personal accountability, product/process compliance and safety oriented.
• Strong written and verbal communication skills with effective documentation skills and ability to communicate at all levels of the organization to drive changes, resolve issues, understand risks to compliance and the business.
• Proficient use of various software applications such as MS Teams, Word, Excel, Access, PowerPoint, Outlook.
• Experienced, practical knowledge and application of the regulations and standards, (e.g. QSR, ISO13485, Quality System Requirements, CFR 211, 820, Part 11, ICH guidelines, Health Canada and Latin America regulations, FDA guidance documents), affecting Medical Device and Pharma manufacturing sites and supply chain as well as Quality System life cycle management.

Abilities

• Multi-tasks effectively, prioritizes and meets deadlines in timely manner.
• Proven ability to work successfully cross-functionally and collaboratively to problem solve, initiate and manage projects/changes, influence internal and external groups and provide leadership from a quality and compliance perspective.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable by setting a strong leadership and compliance-minded example.
• Strong ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve results.

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
• Pizza With the President
• 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)