Quality Engineer

No relocation or visa sponsorship is offered.

Job Summary: The Quality Engineer ensures materials, in-process, and finished products meet ISO 13485 and quality standards. This role also aids in developing processes and standards to enhance departmental efficiency and profitability.

Key Responsibilities:

Develop and improve quality control and product validation procedures.

Program and operate inspection machines.

Lead validation activities for equipment and products.

Support the development and manufacturing of medical products, ensuring regulatory compliance.

Provide guidance on quality assurance throughout the product lifecycle.

Analyze quality data, identify issues, and resolve manufacturing process problems.

Perform process capability studies and recommend quality improvements.

Enforce the Quality System and maintain consistent standards.

Conduct root cause analysis and implement corrective actions.

Qualifications:

Bachelor's Degree in Engineering.

3+ years of quality experience in an ISO manufacturing environment, preferably with ISO 13485.

Experience in product and process validation.

Ability to analyze and interpret blueprints.

Proven ability to manage multiple projects and meet deadlines.

Strong problem-solving skills and root cause analysis experience.

Preferred:

ASQ quality certification.

Experience in a job shop manufacturing environment.

Job Hours:

Core hours: 8 am to 5 pm, Monday through Friday.

Occasional extended hours as needed.

Infrequent travel.