Highlights
Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
Numbers & Facts
| Location | San Clemente, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $32 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
Description
Position Summary
Provide quality support for *** Consumable development and DHF Remediation. The Quality Engineer will support activities such as CAPA investigations, design projects, and will ensure compliance with *** quality system requirements and applicable regulations and standards, such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards.
Essential Duties & Responsibilities
Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. To assure product quality.
Assures conformance with regulations of the FDA and other international regulatory agencies.
Ensure all Quality attributes for design changes are met.
Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc.
Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality.
Support any potential internal and/or external audits and inspections.
Effectively interact with cross-functional team members.
Provide quality support and for on-market product issues. Bring issues to closure and escalating to management for support as necessary.
Work special projects as assigned
Knowledge & Skills
Experience in quality engineering, product design or product engineering.
DHF Remediation
EU Medical Device Regulation 2017/745 (EU MDR)
Quals--
Minimum Qualifications, Education & Experience
Must be at least 18 years of age
Bachelor s degree in engineering (Electrical, Mechanical, Biomedical) or related field from an accredited college or university is required.
Minimum of 0 - 2 years of experience in R&D and/or Quality is required.
Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
Typically requires travel less than 5% of the time
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.