Quality Assurance Engineer II

Teleflex•Mansfield, MA

2d•$87,400 - $131,000

About The Position

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.

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.
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.

Nice To Haves

ASQ Certification (CQA, CQIA, CQE, Green Belt) preferred

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.