Quality Engineer - Onsite

Quality Engineer - Onsite (Urgent Need) –
Millennium Soft Inc

Level of

Experience:

Mid-Level

Employment Type: Contract on W2 (US Citizens, Green Card Holders, EAD, OPT, CPT)

Work Arrangement: Hybrid, 4 days per week in office

Location: Franklin Lakes, NJ

Duration: 12 months

Total Hours/week: 40

Shift: 1st

Industry: Medical Devices Company

Travel: Domestic, occasional

The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices. They handle projects from product inception through launch and maintenance, ensuring products meet quality standards and regulatory requirements.

• Apply technical principles, theories, concepts, techniques and quality sciences/tools consistently.
• Demonstrate proven problem‑solving skills.
• Drive measurable improvements to client processes and procedures.
• Ensure design control and production/process control projects meet applicable regulatory (local and international), corporate and unit requirements.
• Represent Quality on new product development and sustaining engineering projects as a team member.
• Review and provide Quality Engineering approval authority for new and modified design/ process specifications.
• Assist with supplier and internal quality system audits (auditor‑in‑training).
• Perform other duties as required.

• Minimum bachelor’s degree in science, engineering or related discipline.
• Minimum five years of relevant experience or equivalent education and experience.

• Applied knowledge of FDA medical device quality system regulations and international standards (e.g., 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR).
• Understanding of corporate and/or unit requirements.
• Ability to contribute to specific programs and projects.
• Ability to design, analyze data and generate reports for self and junior developers.
• Capability to revise policies and procedures.
• Strong presentation skills.
• Independently determine and develop solution approaches.
• Provide guidance and work direction to junior project developers.
• Perform development work independently with minimal supervision.
• Experience with client software systems used in Quality Systems is desirable.
• Expertise in at least one of the following areas: acceptance sampling, statistical process control, measurement system analysis, quality planning, failure analysis, design of experiments, process mapping, hypothesis testing, descriptive statistics, process capability analysis, basic quality tools (Pareto, box plots, histograms, scatter diagrams), risk management, supplier quality management, auditing, design/development tools, process validation, software validation.