Validation Engineer

Ace Technologies, Inc.; Northfield (MN); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Remote Mondays & Fridays

Onsite Tue-Thu

Job summary

Ace Technologies, Inc. is seeking a Quality Engineer / Quality Compliance Engineer to support remediation efforts across medical devices, OTC products, and cosmetics.

You will uphold quality standards, develop and maintain QMS documentation, and oversee CAPA and supplier quality programs. The role involves leading investigations, coordinating with laboratories, and ensuring compliance with 21 CFR Part 820 and ISO 13485.

Qualifications

• 2–5 years of Quality Engineering experience in medical device or pharmaceutical environments.
• Experience with 21 CFR Part 820 and ISO 13485 is required.
• Hands-on with Device History Files (DHF) and CAPA processes.
• Experience supporting operations, investigations, and compliance activities in regulated settings.

Responsibilities

• Provide Quality expertise in Product Development, QMS, Design Control, CAPA, and CE technical files.
• Lead supplier quality activities, corrective actions, supplier qualifications, and SCAR management.
• Lead investigations of non-conformances and drive CAPA actions to prevent recurrence.
• Ensure regulatory compliance across product lines and perform design documentation reviews.

Skills

Quality Engineering

GxP Compliance

CAPA

DHF

Regulatory Knowledge

Education

Bachelor's degree in Engineering/Science

Tools

SPC

Job description

++QUALITY ENGINEER / QUALITY COMPLIANCE ENGINEER++

our client is looking to hire 15-20 people

Will provide cross-divisional support for remediation efforts. Under broad supervision, responsible for independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMR's, product specifications, design control files, and CE technical files.

MAJOR RESPONSIBILITIES:

• Provide Quality expertise in Product Development, QMS, Design Control activities, Design History Files, CAPA, Risk Management, and CE Technical Files.
• Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
• Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
• Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
• Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
• Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
• Coordinate product testing with internal and external laboratories as required.
• Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.

Education:

• Bachelor's degree in Engineering, Science, Math or other related technical field.

Role Details:

• Work Schedule: Monday--Friday, 8:00am -- 5:00pm
• Hybrid Work Model
• Monday & Friday: Remote
• Tuesday, Wednesday, Thursday: Onsite (no flexibility here) MUST be onsite these 3 days
• Location: Northfield, IL OR Chicago, IL

Candidate Qualifications:

• 2--5 years of Quality Engineering experience
• Medical device or pharmaceutical industry experience required
• Strong working knowledge of 21 CFR Part 820 and/or ISO 13485
• Handson experience with Device History Files (DHF) and CAPA
• Experience supporting operations, investigations, and compliance activities in a regulated environmen