Quality Assurance Engineer II

Position Summary

The Quality Assurance Engineer shall support the facility and departments in the development, implementation, and maintenance of the quality system. This includes supporting both the quality and manufacturing departments with regard to the applicable QSRs and ISO standards.

Principal Responsibilities

•    Drive continuous improvement initiatives focused on enhancing product quality and reliability.
•    Ensure manufacturing processes comply with regulatory and quality system standards, including FDA, ISO 13485, and other relevant industry regulations.
•    Develop, implement, and maintain process control plans and standard operating procedures (SOPs) to ensure consistent product quality throughout production.
•    Collaborate with cross-functional teams, including engineering, supply chain, and production, to identify and resolve quality issues in the manufacturing process.
•    Conduct process validation, ensuring that equipment and processes meet predetermined specifications and quality requirements.
•    Lead root cause analysis and implement corrective and preventive actions (CAPAs) to address non-conformances and improve process performance.
•    Support internal and external audits, ensuring production areas are audit-ready and maintain thorough documentation for compliance.
•    Monitor key performance indicators (KPIs) in manufacturing, driving continuous improvement initiatives to enhance process efficiency and product reliability.
•    Oversee incoming material inspections and ensure supplier quality meets company standards through supplier audits and corrective actions.

Education / Experience Requirements

•    Bachelor’s Degree in Engineering, Chemistry, Physical Science, or related field is preferred, or 3+ years of Quality Assurance experience working in the medical device manufacturing environment (a combination of education and experience will be considered)
•    Experience in the generation and revision of Standard Operating Procedures (SOPs) for various quality and manufacturing-related processes in a medical device environment, preferred.

Specialized Skills / Other Requirements

•    cGMP, QSR, ISO 13485 knowledge base required.
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint. Ability in database development, statistical software and analysis, simulation, word processing for report generation, etc.
•    ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred

The pay range for this position at commencement of employment is expected to be between $87,400 - $131,000 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.