Quality Engineer - Medical Device

Quality Engineer -[Medical Device Exp Required]

Level of

Experience:

Mid Level

Employment Type:
Contract on W2 (US Citizens or GC Holders or EAD/OPT)

Location:
Franklin Lakes, NJ

Duration: 12 Months

Hours per Week: 40.00

Shift: 1st Shift

Client:
Medical Devices Company

Job Category:
Engineering

Job Description

• The Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality Engineering skills for medical devices.
• This person handles projects from product inception through launch and maintenance, ensuring products meet quality standards consistent with corporate and unit policies, while meeting design control and regulatory requirements.

Job Responsibilities

• Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.
• Proven problem‑solving skills.
• Improve client processes and procedures.
• Ensure design control and production/process control projects meet regulatory, corporate, and unit requirements.
• Represent Quality on new product development and sustaining engineering projects.
• Review and approve new and modified design/process specifications.
• Assist with supplier and internal quality system audits.
• Perform other duties as required.

Education and Experience

• Minimum bachelor’s degree in science, engineering, or related discipline.
• Minimum 5 years relevant experience or equivalent education and experience.

Knowledge and Skills

• 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).
• Corporate/Unit requirement knowledge.
• Ability to contribute to specific programs and projects.
• Ensure quality of projects including design, data summary/analysis, and report generation.
• Revise policies and procedures.
• Make presentations.
• Develop solution approaches independently.
• Provide guidance and direction to lower‑level developers.
• Design and perform development work with minimal supervision.
• Experience with client quality systems software desirable.
• Specialization in areas such as acceptance sampling theory, statistical process control, measurement system knowledge, 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.

Seniority level
:
Mid‑Senior level

Employment type
:
Contract

Job function
:
Quality Assurance

Industries
:
Staffing and Recruiting