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Quality Assurance Manager

Company: Lutronic
Location: Billerica
Posted on: September 21, 2022

Job Description:

About the Company: Lutronic Inc., is a leading innovator of aesthetic laser technology in the medical device field. Established in 1997, Lutronic partners with key opinion leaders to advance science and ensure efficacy of its systems 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. Position Summary: Ensures that quality system activities for a US Importer and distributor are completed. This would include FDA registration and listing requirements, quality system training, product complaint oversight, maintaining document control system, review of service records and support as needed to German subsidiary for QA activities required by EU MDR. Job Responsibilities Understand, establish, and implement quality policies and procedures that are compliant with applicable FDA regulations. Maintain and manage the Quality Management System by developing, revising, implementing, and training on quality procedures and forms, and serving as the official Management Representative. Analyze trends and work with other departments to identify potential changes or improvements to reduce or eliminate future customer complaints or compliance issues. Conduct annual Internal Quality Audits to ensure the Company's continued compliance to the applicable FDA 21 CFR regulations. Maintain and manage product complaint files ensuring the Customer Complaints are processed and filed in a timely manner. Ensure that complaint information is provided to Lutronic Corporation on a routine basis as agreed to by Lutronic Aesthetic and Lutronic Corporation. Ensure that Lutronic Corporation provides feedback on corrective actions taken as the result of complaints reported by Lutronic Aesthetic. Maintain and manage Medical Device Adverse Event files including reviewing complaints for reportable events, notifying Lutronic Corp of reportable, processing confirmed reportable events, and submitting MedWATCH forms to FDA in a timely manner. Maintain and manage Service History Records aka Device History Records (DHR) by ensuring all DHR contents are legible and accurate, and ensuring the DHR records are kept in a secure location to prevent mix-ups, deterioration, or contamination over time. Provide Quality System Training for personnel on relevant quality policies and procedures, retrain personnel as needed, and maintain quality training records for all personnel. Ensure that the Company maintains the applicable FDA registrations and listings for facilities and devices. Work with Lutronic Germany to insure that:-Product complaints are documented and maintained-Complaints are forwarded to Lutronic Corp. on a routine basis-Complaints are reviewed for potential reportable events Minimum Requirements/Qualifications Prior experience in Quality Assurance and/or Regulatory Affairs Excellent written and verbal communication skills a must Strong in Microsoft Office Suite applications and tools Ability to operate standard office technology and equipment on a regular basis Strong organizational, documentation, and problem-solving skills Must also have strong interpersonal and relationship building skills Ability to multi-task effortlessly Highly self-motivated employee Ability to work in a challenging, fast-paced and high-growth environment Able to contribute positively as part of a team, assisting with various tasks as needed Desired Qualifications (Work experience, education, skills, competencies) BS or BA in engineering or scientific field preferred 2-3 years relevant experience with quality systemsJob Type: Full-timePay: $49,948.85 - $113,776.95 per yearBenefits: 401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insuranceSchedule: Monday to FridayWork Location: Hybrid remote in Billerica, MA 01821

Keywords: Lutronic, Billerica , Quality Assurance Manager, Executive , Billerica, Massachusetts

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