Associate Quality Engineer
2 weeks ago
POSITION SUMMARY
The Quality Associate assists with technical activities to ensure ongoing product compliance with the company’s quality management systems and objectives. Responsibilities include supporting quality activities (for all stages of product lifecycle) and taking part in cross-functional teams to achieve company goals.
The ideal candidate is a hands-on critical-thinker that can operate independently to achieve shared team goals. This position is a part of the QA/RA team and reports to the Quality Director.
Requirements:KNOWLEDGE AND EXPERIENCE REQUIREMENTS
Education: Bachelor’s degree in a scientific or technical discipline.
Experience: 1+ year(s) experience within a regulated industry (medical device experience preferred), or similar.
Experience with Quality Management Systems and knowledge of ISO 13485.
Other Skills:
- Good mechanical/technical aptitude.
- Effective technical writing and communication skills; good organizational skills.
- Excellent attention to detail.
- The ability to interface professionally and diplomatically throughout the organization is required.
POSITION RESPONSIBILITIES
1. Assist with engineering studies; document process validations and verifications.
- Assist with sterilization monitoring/revalidation, and environmental monitoring programs.
- Assist with implementation of new equipment and maintenance/calibration of existing equipment
- Carry out technical protocols and/or inspection procedures as assigned
2. Document nonconforming product reports and potential rework opportunities
- Provide data trending and perform root cause assessment for corrective and preventative action
3. Perform activities to maintain the effectiveness of the quality system.
- Assist in supplier monitoring and respond to customer compliance requests
- Assist in planning and conducting internal and external audits to assess compliance with quality and regulatory requirements
- Ensure proper documentation and traceability of quality activities and findings
4. Participate in continuous improvement initiatives to enhance product quality, reduce defects, and improve processes
5. Participate in cross-functional development teams to provide product quality insight and feedback.
6. Conduct inspection and quality checks on incoming materials, in-process products, and finished goods to ensure compliance with specifications and standards
7. Assist Quality Assurance, Manufacturing, or other functions as needed.
This position is an on-site position. Not for remote.
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