We are seeking a hands-on Quality Engineer to support manufacturing validation and quality process development within a regulated manufacturing environment.

This role will focus on developing IQ/OQ/PQ validations, establishing in-process quality controls, and implementing batch release procedures. The ideal candidate is a resourceful problem solver who can build validation systems from the ground up and support manufacturing readiness.

Key Responsibilities

• Develop and execute IQ/OQ/PQ manufacturing process validations.
• Establish in-process quality controls, inspection checkpoints, and batch release procedures.
• Assess process risks and evaluate the impact of manufacturing defects on product quality.
• Collaborate with Manufacturing, Engineering, and Product Development teams.
• Develop validation protocols, documentation, and quality procedures.
• Support manual and semi-automated manufacturing processes and new production launches.

Required Qualifications

• Experience working within an ISO 13485 quality management system is required.
• Strong hands-on experience with IQ/OQ/PQ process validation.
• Experience in regulated medical device manufacturing.
• Understanding of process controls, risk assessments, and product quality.
• Ability to develop validation processes and quality systems from the ground up.
• Strong problem-solving skills and ability to work primarily onsite.

Preferred Qualifications

• Experience in Product Development.
• Background supporting new product launches or early-stage manufacturing.
• Experience with manual or semi-automated assembly processes.

Why Consider This Opportunity?

• Play a key role in launching a new manufacturing program.
• Build validation processes and quality controls from the ground up.
• Work closely with cross-functional engineering and manufacturing teams.
• Make a direct impact on manufacturing readiness, product quality, and process reliability.