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.
