Quality & Process Validation Engineer

Job Title : Quality & Process Validation Engineer

Location : Latham, NY

Experience : 5+ years

Employment Type : 12+ months Contract

Job Overview :

We are seeking a detail-oriented and highly skilled Quality & Process Validation Engineer to join our medical device manufacturing team. In this role, you will plan, execute, and document process validation activities to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other regulatory requirements. You will collaborate closely with R&D, manufacturing, and quality teams to ensure robust, compliant, and efficient production processes.

Key Responsibilities :

Develop and execute IQ, OQ, and PQ protocols for equipment, utilities, processes, and software used in medical device manufacturing.

Conduct risk assessments (e.g., pFMEA) and participate in cross-functional risk management activities in line with ISO 14971.

Author and review validation plans, reports, and supporting documentation per regulatory and internal QMS standards.

Coordinate with engineering, manufacturing, and quality teams to ensure timely and compliant validation activities.

Lead or support process characterization, capability studies, and statistical analysis (e.g., Gage R&R, DOE, SPC).

Support technology transfers and new product introductions (NPI) by validating processes and equipment at internal or contract manufacturing sites.

Ensure ongoing process verification (OPV) and participate in continuous improvement and CAPA investigations.

Maintain validation traceability and documentation in accordance with Good Documentation Practices (GDP).

Oversee validation lifecycle management, including revalidation triggers and periodic reviews.

Stay updated on relevant standards, guidance documents, and industry best practices (e.g., FDA guidance, GAMP 5, ISO / TR 24971).

Required Qualifications :

Bachelor's degree in Engineering (Mechanical or equivalent).

5+ years of experience in process validation within a regulated medical device manufacturing environment.

Strong knowledge of ISO 13485, 21 CFR Part 820, and related validation standards.

Hands-on experience with IQ / OQ / PQ protocols, statistical tools (Minitab preferred), and risk management tools.

Knowledge of GD&T, reading technical drawings, CMM, jigs & fixtures, and manufacturing processes.

Experience with welding, soldering, sterilization, molding, assembly, packaging, or similar manufacturing processes is highly desirable.

Excellent written and verbal communication skills, with strong attention to detail.

Ability to manage multiple validation projects and collaborate effectively within a team environment.