Job Description

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.

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