Quality Engineer I

TekWissen • Parsippany, NJ

6d • Onsite

About The Position

The Quality Engineer I is an entry-level position responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. The role interacts with multiple functional departments, suppliers, and external experts to implement Client quality goals and support continuous improvement initiatives.

Requirements

• Ability to work effectively within a team environment and build relationships across departments and with external stakeholders, including suppliers and regulatory agencies.
• Strong results orientation with the ability to meet deadlines and deliver quality outcomes.
• Effective verbal and written communication skills with the ability to interact at multiple organizational levels.
• Demonstrated potential for future development and growth opportunities.
• Proficiency with Microsoft Office Suite.
• Basic knowledge of blueprint reading and geometric dimensioning and tolerancing (GD&T).
• Basic understanding of QSR/ISO regulations, Design Assurance, Failure Mode and Effects Analysis (FMEA), and product testing methodologies.
• Experience using measurement and inspection tools such as optical comparators and coordinate measuring machines (CMMs).
• Bachelor's degree in Engineering or an alternative Bachelor's degree program with certification as a Quality Engineer (e.g., Certified Quality Engineer (CQE)).

Nice To Haves

• Certified Quality Engineer (CQE) certification preferred.
• Experience within the medical device industry, particularly the orthopedic industry, preferred.

Responsibilities

• Formulate procedures, specifications, and standards for Client products and processes.
• Develop and implement corrective and preventive action plans.
• Collect and analyze data for gauge and product evaluation.
• Identify critical personnel, gauges, procedures, and materials needed for the completion of new products.
• Ensure suppliers have the necessary information and facilities to deliver quality products that meet established requirements.
• Collaborate with cross-functional teams to support quality assurance objectives and product compliance initiatives.

What This Job Offers

• Career Level: Entry Level