Quality Control Manager
+ location:Sunnyvale, CA
+ salary:$75 - $100 per hour
+ date posted:Thursday, August 22, 2019
+ job type:Temporary
+ industry:Miscellaneous Manufacturing Industries
Quality Control Manager
Randstad Staffing has an immediate Quality Manager role in Sunnyvale, CA at a leading Women's Health Medical Device Manufacturer.
-Responsible for ensuring that Quality Management System (QMS) is compliant with required regulations (e.g. FDA Quality System Regulation, European Union Medical Device Regulation, Health Canada Medical Devices Regulations, Brazil RDC No. 16, MHLW Ministerial Ordinance No. 169, Therapeutic Goods Regulation 2002, etc.) and applicable standards (ISO 13485:2016). Drives activities to maintain compliance and to meet new regulatory requirements.
Supports audits/inspections with Notified Body (CE marking) and FDA (and other regulatory agencies). Develops responses to any corrective actions required. Performs follow-up activities to assure agreed upon corrective actions have been implemented.
May act as Management Representative (MR) as required.
Manages and maintains the following functions / processes within the Quality Management System, including:
Corrective & Preventive Action
Internal Audits ?? develops and maintains audit schedule, performs
routine and non-routine audits of the QMS.
Responsible for management and execution of Supplier Quality Management activities (qualification, auditing, performance, etc.)
Participates in local Management Quality Review Meetings. Prepares and presents reports assessing the suitability and effectiveness of assigned areas of the quality system.
Reviews and approves Quality Management System change orders for the Quality Assurance Function.
Provides appropriate training on quality system procedures as required and complies with all quality system procedures.
Working hours: 8:00 AM - 5:00 PM
- Excellent working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, MDD, CMDR, MHLW Ministerial Ordinances and Brazilian requirements.
- Certified Manager of Quality, Quality Engineer and/or Quality Auditor preferred.
- Knowledge in device regulatory affairs would be helpful. Computer literate: able to use word processing, spreadsheet programs, databases.
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations
- Excellent writing skills with ability to write quality assurance reports and detailed procedures.
- Strong knowledge of corrective action, problem solving and root cause analysis processes and tools.
- Strong ability to effectively present information and respond to questions from senior management, function heads, managers, supervisors and all levels of employees.
Excellent interpersonal skills to interact with all levels of the company, sometimes in an adversary role.
Bachelors degree (BA or BS) in a technical discipline preferred.
4-6 years related experience in a medical device or pharmaceutical company or equivalent combination of education and experience required.
Please contact Paul Robillard to review resumes and schedule interviews at 781-999-7361
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