Quality Engineer – PULSE SYSTEMS Concord, CA Vacancies in Actalent Concord, CA
This Jobsfunter Listing is about Actalent in Concord, CA 2022
About the job
Looking for a Quality Engineer for Pulse Systems here in Concord, CA. Candidate who have experience with ISO 13485 and auditing please apply!
- Responsible for developing and improving the corporate Quality System in conformance to FDA and ISO standards appropriate for world-class suppliers to the medical device industry with the following areas of responsibility:
- Provide support when needed in-process and final inspection processes.
- Participate in the resolution of all product rejections and returns, internal and external, call and follow-up on Material Review Board Meetings.
- Provide technical support for inspection department.
- Internal Audits – Schedule and manage internal quality audits.
- Third Party Audits – Participate in external quality audits and surveys from customers and regulatory agencies.
- Ensure timely response to all customer-inquiries including complaints, customer generated Supplier Corrective Action Requests (SCAR’s), and Pulse Systems issued SCARs.
- Track and manage the timely resolution of all customer inquires, open SCAR’s.
- Corrective and Preventive Actions
- Ensure Corrective And Preventive Action (CAPA) activities are initiated when required.
- Monitor CAPA activities from initiation, through closure, and verification of effectiveness.
- Train employees, including management, in quality processes and regulatory requirements.
- Monitor internal training activities to ensure all employees are trained in accordance with Pulse Systems procedures.
- Vendor Evaluation and Approval
- Manage Vendor Evaluation/Approval/Review process. Conduct Supplier Audits as required
- Issue and manage Supplier Corrective Action Requests as required.
- Document Change Orders
- Skills:* capa, medical device, customer service, iso 13485, audit
- Top Skills Details:* capa,medical device,customer service,iso 13485
- Additional Skills & Qualifications:*
- Work with other departments to define, qualify, and implement Document Change Orders.
- Manage the Document Control process to maintain revision control on all internal controlled documents.
- Ensure that Document Change Orders are tracked and implemented in a timely manner.
- Support the execution of production schedules consistent with company goals and objectives.
Coordinate support from other staff and production personnel as necessary.
- Be a company champion for quality and compliance.
- Prepare materials for and participate in Quality review meetings with management.
- Adhere to general safety rules, manufacturing procedures, company policies and procedures and other ISO guidelines.
- Work from limited direction as set by the Head of Quality (currently Director of Engineering and Quality).
- Experience Level:* Entry Level
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Vacancy Type: Full-time · Entry level
Job Location: Concord, CA
Application Deadline: N/A