Quality Engineer Validation Focus

Quality Engineer

St. Paul, MN Direct Hire $75k - 90k

Konik is partnering with a local pharmaceutical manufacturer, seeking an experienced Quality Engineer to support process development, design transfer, and commercial production of pharmaceutical and medical device products. This role ensures compliance with regulatory requirements and customer specifications, with a focus on pharmaceutical film products. Key processes include mixing, coating, slitting, converting, and packaging.

Quality Engineer Responsibilities:

Process & Product Development: Support product development from feasibility to validation, ensuring robust processes using Quality by Design (QbD) principles and Design of Experiment (DoE) methodologies.

Risk Management: Conduct risk assessments, including Failure Mode and Effects Analysis (FMEA), Annual Product Reviews, and process verification to identify and mitigate potential failures.

Regulatory Compliance: Develop and maintain documentation such as batch records, protocols, reports, and SOPs in compliance with cGMP, ISO, and industry standards.

Change Control & Deviations: Lead root cause investigations, implement corrective actions, and assess the impact of changes on quality and compliance.

Cross-Functional Collaboration: Work closely with R&D, manufacturing, and regulatory teams to improve internal processes and ensure seamless design transfer to production.

Equipment & Facilities Support: Assist in qualification and validation of equipment, systems, and software, ensuring alignment with industry best practices.

Quality Engineer Qualifications:

Bachelor’s degree in engineering, life sciences, or related field.

5+ years of experience in a quality role within pharmaceutical, biopharmaceutical, or medical device industries.

Strong knowledge of manufacturing processes, cGMP, ISO, and regulatory guidelines.

Experience with risk management, quality systems, and process validation.

Benefits:

Health, Dental, and Vision insurance

Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA)

Vacation & Sick Time

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Konik is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception, and maintains a strong commitment to customer service.

Compensation:

$75,000-$90,000 per year