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MV02-030526 Sr. Quality Engineer

Validation & Engineering Group
Louisville, United Statesfull_timeVerifiedPosted 5 Mar 2026

About the role

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Sr Quality Engineer

Job Summary:
The Senior Quality Engineer will lead the design, authoring, and implementation of Quality Management System (QMS) documents, ensuring alignment with company objectives. The role includes developing SOPs, conducting GMP training, supporting controlled rollout of QMS documents, and driving operational excellence through continuous improvement initiatives.

Qualifications:
- Bachelor’s degree in Engineering or a relevant, similar field.
- Minimum of 5 years of experience in quality engineering, specifically in Pharma/GMP/GxP environments.
- Proficient in developing and implementing QMS documents and SOPs.
- Strong understanding of quality control principles and methodologies.

Responsibilities:
- Support the establishment of the QMS structure, document hierarchy, and governance model.
- Develop quality policies, objectives, and management review framework.
- Author, customize, and standardize GMP documentation for all company facilities.
- Support the implementation of quality processes, conduct GMP training, and ensure GMP readiness.
- Evaluate current operational workflows, identify areas for improvement, and develop optimization recommendations.

The ideal candidate will support the establishment of the QMS, SOP development, and employee training.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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Company

Validation & Engineering Group

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