Quality Assurance Specialist
-
Quality Assurance - QA/QC
Quality Engineering, Quality Control - QC Analysts/Managers, Production QC/QA, Regulatory Compliance Specialist
Job Description & How to Apply Below
Are you looking for a rewarding career in manufacturing? If so, IPG Photonics may be the place for you! Working with IPG Photonics you can expect interesting tasks and challenging projects as well as a motivating and friendly environment. You will be working with teams that influence the future of laser technologies.
IPG Medical, a wholly owned subsidiary of IPG Photonics (NASDAQ: IPGP), is focused on developing next-generation products based on IPG Medical's state-of-the-art laser technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.
Responsibilities:- Review and approve incoming inspection reports as well as non-conforming material reports for conformity to specifications
- Support manufacturing operations through timely review ofDHR's including release of finished goods
- Adhere to good manufacturing practices and good documentation practices
- Participate in CAPA's to better improve company practices and systems
- Member of the Material Review Board of non-conforming material
- Train Quality Inspectors on good document practices, standard operating procedures and QC processes
- Assist in both internal and external audit preparation, support Quality management team during audits
- Promote awareness, visibility and communication relative to QMS goals and initiatives
- Other duties as assigned
- High School Diploma or equivalent is required,Bachelor's degree in scientific, biomedical, or engineering discipline preferred
- 5-7 years of experience in Medical Device Quality Assurance required
- Solid understanding of ISO
13485, ISO
14644, andCFR 21-820 - Prior experience working in a clean room
- User experience of QMS, PLM and CMMS systems
- Strong working knowledge of Microsoft Word and Excel
- Strong oral, written and interpersonal skills required for interaction within group and other departments
- Organizational skills and attention to detail
- Results-oriented, with ability to multitask
- Self-motivated and proactive
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).