Sr Quality Assurance Engineer

3 weeks ago

Santa Clara, United States Cordis Full time

Overview The Sr Quality Assurance Engineer partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing in line with Cordis policies and procedures. Provide quality assurance support to all functions with focus on compliance in accordance with ISO 13485, 21 CFR Part 820 and 93/42/EEC. Provide regulatory support and assist with various ongoing projects to remain in compliance with all FDA and other U.S. and international regulatory requirements. Please note, at this time Cordis is not sponsoring applicants for any type of work visas. It is a condition of employment that an applicant is authorized to work in the U.S. Responsibilities The position is primarily responsible for ensuring that quality audit programs and regulatory submissions comply with external regulations. • May perform as CAPA Coordinator to ensure CAPA Timeliness and the CAPA process is followed appropriately. • May perform as Non-Conformances Coordinator to ensure NCs Timeliness and the NC process is followedappropriately. • May manage the training process to ensure the process follows internal requirements and it is adequate. • Provide support on addressing and solving issues related to incoming inspection or final release processes. • Assist in the preparation of the Management Review meeting presentations on a quarterly basis. • Report on quality systems in quarterly Management Review meetings. • Prepare and coordinate regulatory filings such as IDE, PMA and Design Dossier submissions andsubsequent revisions/supplements and amendments. • Attend project team meetings on a regular basis and provide assistance with regulatory strategies forvarious projects. • Review and approve complaint, CAPA, NCs, Supplier CAPAs, and Audit Observation investigations. • Prepare international product registrations and licensing documentation. • Provide continued quality system support by improving processes and systems and by updating andcreating site procedures. • Participate in third party (Notified Body, FDA) and internal audits as required. • May manage key quality system programs such as CAPA, environmental monitoring, CER recertification,and shelf life establishment. • Provide support to manufacturing lines to address issues and escalate issues to NC or CAPA process asneeded. • Work with Distributed Product Risk Assessments (DPRAs) as needed. • May lead Quality initiatives as part of a high standard quality culture. • May supervise personnel at a Technician level as required. • Ensure Site Metrics are complying with internal requirements and goals established. • Work with medium complexity projects to ensure process improvement is continuously followed. • May provide coaching to technicians to promote people development and process improvement culture. • May provide testing support in on-site microbiology lab with Bacterial Endotoxin Test (BET) including preparation, review of lab test reports and management of the lab. Qualifications Bachelor’s Degree in related discipline and a minimum of 4 years in the medical device/pharmaceuticalfield, or equivalent combination of education and experience. Expertise in the FDA Medical Device Quality system Regulation, MDD 93/42/EEC and ISO 13485 Experience and involvement in MDRs, IDEs, PMA, and 510(k) filings is preferred Excellent oral and written communication skills Proven ability to create improvements in processes and systems Effective interpersonal skills Ability to comprehend principles of engineering, physiology, and medical device use CQE preferred Auditor Certification preferred. Pay / Compensation The expected pre-tax pay rate for this position is $105k - $115k Actual pay may differ depending on relevant factors such as, but not limited to, prior experience or education. Benefits: Cordis offers a competitive benefits package including: 401(k) Medical, Dental and Vision Insurance Life insurance Paid time off JOIN OUR TALENT COMMUNITY Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests. Job Locations US-CA-Santa Clara ID 2024-2898 Category Quality/Regulatory Position Type Regular Full-Time CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com

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