We are hiring QA Specialist/ Analysts with exp in Medical Devices for our client in Indianapolis.
We are looking for a highly motivated Quality Specialist to ensure that all processes and products meet or exceed the quality standards set forth by our company, regulatory bodies and customer requirements.
•Oversee development & improvements to Quality system.
•Ensure quality system requirements are established, implemented, and effectively maintained.
•Report on the performance of the quality management system and any need for improvement to management that has executive responsibility.•Ensure the promotion of awareness of regulatory and customer requirements throughout the organization
•Manage Complaint Handling system and lead all Quality Assurance and Quality Control activities.
•Liaison with external parties on matters relating to the quality management system and FDA.
•Oversees all project support and regulatory submissions.
•Manage quality requirements with contract manufacturer including regular audits
•Works to maintain regulatory compliance with the relevant elements of the US Food and Drug Administration (FDA) Quality System Regulation (21 CFR 820), ISO 13485, European MDR (Medical Device Directive 2017/745), and the requirements of any/all other countries where the company currently conducts business or will in the future.Qualifications
•Ability to think strategically, define problems, collect data, establish facts and draw valid conclusions.•Considerable personal experience presenting, interacting, and building effective relationships with internal management teams, customers, and regulatory agencies
.•Strong communication and presentation skills (articulate and persuasive).
Ability to effectively implement continual improvement to increase efficiency and promote simplification while maintaining or increasing compliance
.•Requires a bachelor’s degree in a related field or equivalent experience.•Must have knowledge of relevant regulatory standards and applicable regulations, including, but not limited to, expertise in FDA QSR, ISO 13485:2016, ISO 14971, and European Medical Device Directive/Regulations. Experience writing MDR documentation.
•Experience writing & routing of CAPAs & NCs and handling complaints & customer feedback.
•Proven track record of successful FDA/regulatory inspections/audits.•Experience implementing a quality management system.
•Experience managing or implementing state of the art Quality Management System software application tools.
•Experience working with contract manufacturers and auditing suppliers.
We won't work a search for a job we would not want.
We prefer to do things the old fashioned way, we talk to you. Let's see if this is a fit.