Job Title: Senior Quality Assurance Specialist
Region: USA - Hybrid
About the Company
Lutronic, a leading innovator of aesthetic and medical advanced laser and related technology, was established over 19 years ago to bring intuitive, robust, versatile devices which are affordable and efficacious to the worldwide medical community. Committed to improving medicine, Lutronic partners with key opinion leaders to advance science and ensure efficacy of its systems. All systems are versatile and offer multiple setting and treatment options for customized treatments, which optimize outcomes for a wide variety of conditions and treatments including melasma, tattoo removal, soft tissue incision, vascular, hair removal, wrinkles reduction, rejuvenation, body/face contouring, chronic pain, healing and more.
Come join our team!
Lutronic is searching for a Senior Quality Assurance Specialist as a result of internal Talent movement. This matrixed position reports into the VP of Regulatory Affairs and works closely with other functional teams including Services, Clinical Training, as well as the QA team at the manufacturing site.
Hybrid While this is a hybrid role, there is an expectation that the incumbent is available to commute to Billerica, MA 2-3 days per week.
In this role, you are responsible for ensuring all quality system activities for a USA Importer and Distributor are completed. This includes but not limited to maintaining the document control system, quality system training, product complaint oversight, Management Reviews, Review of Records, and providing support to Lutronic’s European subsidiary for QA activities required by EU MDR.
Job Responsibilities include
- Understands, establishes, and implements quality policies and procedures which are compliant with applicable FDA regulations.
- Maintain and manage the Quality Management System.
- Conduct annual Internal Quality Audits to ensure the Company’s continued compliance to the applicable FDA 21 CFR regulations.
- Maintain and manages product complaint files ensuring the customer complaints are processed and filed in a timely manner.
- Provides manufacturer feedback on a routine basis and ensures corrective actions are taken as a result of complaints reported.
- Maintain and manage Medical Device Adverse Event files including reviewing complaints for reportable events, notifying manufacturer, processing confirmed reportable events and submitting MedWATCH forms to FDA in a timely manner.
- Maintain and manage Service History Records by ensuring all contents are legible and accurate, and ensuring the records are kept in a secure location to prevent mix-ups, deterioration, or contamination over time.
- Provides Quality System Training and retraining as identified for personnel and maintains all quality training records.
- Works with Lutronic Germany on timely reporting and documenting of product compliants.
- Prior experience in Quality Assurance is necessary.
- Proven experience managing product compliant files and addressing customer complaints in a timely manner.
- Excellent written and verbal communication skills a must.
- Outstanding organizational, documentation, and problem-solving skills.
- Strong interpersonal and relationship building skills.
- Enate ability to balance work and comfortable shifting priorities accordingly.
- Highly self-motivated employee who embraces a challenging, fast-paced, hyper-growth environment.
- Has a team contribution mindset and supports completion of other various tasks as needed.
- Well versed in Microsoft Office applications and tools, including Outlook, Word, PowerPoint, Excel, and others.
- Ability to operate standard office technology and equipment on a regular basis including copier, computer, and phone.
Key Attributes to Help You Stand Out:
- BS or BA in engineering or scientific field preferred.
- 5+ years relevant experience with quality systems.
If you are looking for a fun, fast-paced growing company that values our team and offers products our customers love, we encourage you to apply today at www.lutronic.com.