Mission

The Senior Quality Assurance Engineer provides leadership to the quality technical team taking responsibility for process and design validations, data analysis, and quality improvement projects.

Key responsibilities

• Develop and improve validation and other related standards (SOPs)
• Participate in the product development process as required to ensure that customer requirements and regulations are met.
• Develop and lead product validation testing, test methods, protocols, and issue reports, as needed.
• Lead the process and product FMEA, and Risk Management activities.
• Monitor and analyze effectiveness of process controls in support of validation maintenance.
• Determine appropriate actions (continuous improvement and/or corrective actions) if processes are identified as ineffective.
• Lead and facilitate CAPA project teams as required to ensure continuous quality improvement.
• Lead the development, execution, analysis and reporting of first-article qualification and process validations at both SAI and supplier facilities as required.
• Perform and document equipment and process Capability Studies.
• Develop and prepare facility quality performance reports, charts, and graphs as needed for management decision making.
• Identify and lead six sigma projects assigned by SAI Management.
• Provide technical leadership for the quality team
• Support the internal auditing program.
• Other duties as assigned by Quality Management.

What we’re looking for

• Bachelor of Science in Engineering
• Minimum 5 years Quality experience in a medical device manufacturing facility.
• Experience with continuous improvement projects
• Experience with process validation
• Knowledge of FDA regulations and ISO 13485 standard.
• Demonstrated proficiency in the use of databases, spreadsheets, and statistical software, preferably Minitab
• Must possess excellent team-facilitation skills, advanced problem-solving skills
• Strong verbal communication and technical writing skills
• Proficient in Microsoft Word, Excel, and Project management software
• Ability to work independently
• Management: the ability to organize and manage multiple priorities.
• Ability to communicate, interact and work effectively with people from diverse ethnic and educational backgrounds, as well as across all levels of the organization

Authorities

• This position is authorized to perform all tasks and duties where defined in Standard Operating procedures, and as outlined within the “essential functions” of this position description.
• This position is authorized and encouraged to report unsafe conditions, unsafe acts, violations of quality, safety, environmental or financial procedures and unethical business practices to the department manager or to HR.

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. To comply with these laws, the employer invites employees to voluntarily self-identify their gender, 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. QA Engineer is $93,012-139,518. 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.