Sr. Engineer, Quality - Defined Term

Getinge•Smithfield, RI

1d•$115,000 - $135,000•Onsite

About The Position

The Senior Quality Engineer will play a critical role in ensuring the quality and reliability of our products (bioprocessing consumables) from the design phase through production. This position involves working closely with design, engineering, and manufacturing teams to identify and mitigate quality risks, implement quality control processes, and ensure compliance with industry standards and regulations.

Requirements

Bachelor’s degree in Science or Engineering discipline, or equivalent combination of education and experience required.
5 years of experience in Quality, Manufacturing or related field in a GMP manufacturing environment specifically including new product introduction/design and development (pharmaceutical industry preferred).
Demonstrated knowledge of current Good Manufacturing Practices (cGMP) and other related regulations.
Experience with quality management software required (ETQ Reliance preferred)
Proficient with Microsoft Office Suite.
Cleanroom experience required.
Strong knowledge of design quality assurance principles, methodologies, and tools.
Experience with design verification and validation processes.
Experience with plastics manufacturing (injection molding, 3D printing, etc.)
Familiarity with industry standards and regulations (ISO 9001).
Strong communication and interpersonal skills.
Ability to work effectively in a cross-functional team environment.
Proficiency in quality management software and tools.
Strong self-initiative and the ability to work independently to achieve results
Strong problem-solving and risk-based decision-making abilities.
Strong grasp of manufacturing systems and processes.
Excellent organizational skills and attention to detail.

Nice To Haves

Certified Quality Engineer, Six Sigma Black Belt, or other relevant certifications preferred

Responsibilities

Collaborate with design and engineering teams to develop and implement quality assurance plans for new products.
Coordinate design for manufacturability activities with design and manufacturing teams to ensure designs are optimized for manufacturability, reducing production costs and improving product quality.
Coordinate and drive design for reliability activities with design teams to ensure designs are suitable to function reliably in the hands of our customers during the intended use and lifetime of the product.
Conduct design reviews and risk assessments to identify potential quality issues and ensure design robustness.
Develop and maintain quality control documentation, including design verification and validation plans, test protocols, and inspection criteria. Ensure all design and quality documentation is accurate, up-to-date, and properly controlled.
Oversee the testing and evaluation of prototypes to ensure they meet design specifications and quality standards.
Perform root cause analysis and implement corrective and preventive actions (CAPA) for design-related quality issues.
Provide quality support during product launches to ensure a smooth transition from development to production.
Ensure compliance with relevant industry standards and regulations, such as ISO 9001.
Support continuous improvement initiatives by analyzing quality data and implementing process improvements.
Provide training and guidance to team members on quality assurance best practices and methodologies.
Participate in supplier quality management activities, including supplier audits and evaluations.