Quality Engineer II

Our client, a global Medical Technology corporation with singular focus on Diabetes management and treatment solutions and leader in Insulin delivery products for >30 million people in >100 countries, seeks an accomplished Quality Engineer II

Position:
Quality Engineer II

DIRECT HIRE FULL TIME

Salary: $65k – 75k annually

H1B/ C2C/ VISA SPONSORSHIP: NO

As directed by the Quality Engineering Leader, the Quality Engineer II is responsible for supporting new product development and product sustaining activities through the application of quality engineering principles within a medical device environment.

For New Product Development
, this role manages projects and tasks from product inception through launch and maintenance, ensuring compliance with corporate policies, design control requirements, and regulatory standards.

For Sustaining Products
, this position focuses on understanding, improving, and controlling operational processes to ensure predictable product flow and adherence to established embecta quality standards.

The Quality Engineer II works closely with quality management, operations, suppliers, and embecta associates to ensure compliance with all company quality policies, procedures, and practices.

• Support plant product initiatives by providing technical expertise and identifying necessary resources to meet project goals.
• Provide quality engineering direction to Project Pearl, utilizing tools and principles such as:
• Root cause analysis
• FMEA
• Validation
• DOE and other process improvement tools
• Measurement systems analysis
• Sampling and control plans
• Apply moderate-level technical principles, theories, concepts, and quality sciences/tools.
• Develop solutions to routine problems of moderate scope.
• Maintain alignment with company quality policies, procedures, and practices through sound quality assurance principles; make basic procedural updates as needed.
• Demonstrate working knowledge of applicable regulatory, Corporate, and/or Unit requirements.
• Serve as Site Quality representative on product development projects and as a team member for sustaining engineering projects.
• Establish strong working relationships across operations to monitor and analyze:
• In-process inspection
• Process control activities
• Waste and reject rates
• Preventive maintenance compliance
• Lead identification and documentation of continuous improvement projects.
• Approve validation and change control protocols and reports to ensure compliance with established procedures.
• Utilize Lean and Six Sigma methodologies, data analysis tools, and techniques to support validation and continuous improvement efforts.

• Bachelor’s degree in Engineering (Industrial, Mechanical, or similar).
• 3+ years of Quality experience, including validation and Quality Engineering responsibilities.
• Demonstrated success with statistical and problem-solving methodologies.
• Strong knowledge of Quality Engineering and Quality Management principles related to validation processes for medical devices.
• Proficiency in Minitab (or other statistical software), MS Word, Excel, and MS Project.

• Strong understanding of failure analysis, test methods, and engineering tolerances.
• Strong verbal, written, and interpersonal skills.
• ASQ Certified Quality Engineer (CQE).
• Working knowledge of 21 CFR 820, 21 CFR 210, 21 CFR 211, and ISO 13485.
• Certified Quality Engineer and Certified Quality Auditor (preferred).

Sajag Bhardwaj

Email: sajag.

I’d love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you’re looking for rewarding employment and a company that puts its employees first, we’d like to work with you.

Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid‑sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently,…