The Senior Quality Engineer is responsible for developing, maintaining, and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 9001, ISO 13485, and FDA 21 CFR Part 820. This role supports compliant/CAPA investigations, supplier quality improvement, operations production and process controls, QA/QC release inspection and documentation, and product and service quality improvement with the use of statistical techniques and other accepted quality principles. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of Lazurite Holdings LLC quality systems.
· Participate in cross-functional new product development teams with a focus on the execution of quality plans and design transfer.
· Develop and implement statistically valid sampling plans, designed experiments, capability studies, and trend analysis.
· Lead and/or participate in process and product corrective actions and problem-solving activities.
· Constantly review the current quality system and recommend/implement improvements as needed.
· Review collected data to perform statistical analysis and recommend process/product changes to improve quality.
· Lead projects focused on the quality system, product quality, and service quality improvement.
· Report on the performance of the quality system.
· Participate in strategic planning and audits of internal and supplier quality systems.
· Participate/support external and internal quality system audits.
· Instruct colleagues in quality principles, effective corrective actions, and valid statistical techniques.
· Collaborate with other departments and facilities within the company on quality-related issues.
· Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
· Perform and document QC/QA release activities at supplier sites related to manufacturing release.
· Perform all other duties as assigned.
· Assist Product development team with verification, validation, and other testing needs.
· All other tasks as assigned by management.
- 6+ years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
- 6+ years of experience with medical devices or other regulated industries preferred.
- 6+ years of experience working in an ISO certified environment required.
- ASQ, QSR or familiarity with QSR/GMP regulations preferred.
- Excellent problem-solving skills
- Focus on identification of potential issues and continuous improvement.
- Experience working on cross-functional teams and on their own initiative.
- Demonstrated excellent organizational, oral, and written communications skills.
- Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
- Experience with statistical analysis software and Visio preferred.
- Travel to supplier sites will be required.
- Standard computer skills (Microsoft Office, Outlook).
- Cloud-based document sharing platforms (Google Drive, Dropbox, Monday.com).
- Business tools (Google/Outlook Calendar, Adobe Acrobat DC, Slack).
- Creativity software (Adobe InDesign, Adobe Illustrator, Adobe Photoshop).
- Regularly spend long hours sitting or standing and using office, lab equipment and computers
- Regularly work on repetitive tasks
- Regularly use hands and fingers to handle, control or feel objects
- Regularly hold the arm and hand in one position or hold the hand steady while moving the arm
Job Type: Full-time
Pay: From $70,000.00 per year
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Ability to commute/relocate:
- Cleveland, OH 44128: Reliably commute or planning to relocate before starting work (Required)
- Why are you interested in this role?
- This is not a remote position. Is this what you are looking for?
- What is your desired salary range?
- Bachelor’s (Required)
- embedded CPU and microcontroller-based hardware design: 5 years (Required)
- low power design, management, & battery powered operation: 5 years (Required)
- Altium &/or Eagle schematic capture & PCB layout tools: 5 years (Required)
Willingness to travel:
- 50% (Required)
Work Location: 4760 Richmond Rd, Cleveland, OH 44128