Quality Engineer

Job Title: Quality Engineer Location: Denville, NJ Employment Type: Contract (Independent Contractor, Full-Time) Contract-to-Hire Potential: Yes (Eligible for full-time employment after 1 year) Sponsorship: Not available Relocation Assistance: Not provided About the Company Our client is a rapidly growing, patient-centric medical device company developing next-generation hydraulic drug delivery systems.

Their mission is to improve global access to life-saving injectable medications by creating compact, on-demand solutions that prioritize mobility and quality of life.

With a highly cross-functional and passionate team, they foster an environment where innovation, accountability, and collaboration thrive.

Position Overview We are seeking a Quality Engineer with extensive experience in medical devices or combination products.

The ideal candidate will bring 8+ years of hands-on quality engineering and inspection experience, and will play a vital role in qualifying lab equipment, supporting documentation and testing, and maintaining regulatory compliance.

You will contribute to equipment calibration, preventive maintenance, protocol development, batch reviews, and quality documentation in accordance with FDA QSR and ISO standards.

Key Responsibilities Develop and execute protocols to support lab qualification and validation.

Calibrate and maintain lab equipment and coordinate preventive maintenance schedules.

Participate in product inspection (incoming, in-process, and final), first article inspection, and release activities.

Interpret technical drawings and specifications to determine inspection methods and tolerances.

Maintain compliance documentation including GMP files, calibration logs, training records, and batch release documentation.

Support internal audits and Management Review processes.

Conduct lab testing as needed and input data into digital systems for analysis.

Assist in the creation and maintenance of Quality Management System (QMS) documentation.

Collaborate with cross-functional teams including R&D, manufacturing, and supply chain.

Qualifications Required: 8+ years of quality engineering or inspection experience in medical devices or combination products.

Strong working knowledge of FDA QSR, ISO 9001, and ISO 13485.

Skilled in reviewing and interpreting engineering drawings and specifications.

Demonstrated experience with quality inspection tools and equipment calibration.

Proficiency with Microsoft Excel, Word, and general digital documentation systems.

Strong verbal and written communication skills.

Familiarity with basic statistics; knowledge of statistical software is a plus.

Strong math skills and attention to detail.

Preferred: Certifications such as Certified Mechanical Inspector (CMI) or Certified Quality Technician (CQT). Experience with cleanroom environments and component qualification.

Experience supporting combination product development under design control processes.

Education High School Diploma or equivalent required.

Associate or Bachelor’s degree preferred.

Technical training in engineering, quality systems, or regulatory affairs is advantageous.

Physical Requirements Ability to lift up to 20 lbs.

Must be able to stand for extended periods (up to 4 hours). Occasional travel required (approximately 5%) for supplier audits or project support.

Industry Medical Equipment Manufacturing / Combination Products

Full-Time