Overview
Quality Assurance Officer at MIT spin-off medical device startup Jobs in Boston, MA at PASCALL SYSTEMS INC.
LightScalpel, an American based surgical carbon dioxide laser designer and manufacturer located in Bothell, Washington, is looking for a Quality Control Technician to join our Quality team.
The Quality Control Technician assists in implementing quality control systems, supports manufacturing processes, participates in internal and supplier audits, and performs visual, dimensional, and functional inspection and testing of raw materials, in-process products, and/or finished products to ensure defined quality standards for durability and function are met.
Essential Duties and Responsibilities:
Assist in the development and implementation of quality control processes and systems.
Support root cause analysis and corrective actions for quality issues.
Collaborate with cross-functional teams to ensure quality standards are maintained throughout the product lifecycle.
Maintain quality systems documentation, including standard operating procedures (SOPs) and work instructions.
Participate in risk assessments and support mitigation plans. Identify opportunities for process improvements and support the implementation of changes to enhance product quality and operational efficiency.
Support internal and external audits, including preparation, execution, and follow-up on audit findings. May assist the QA/RA Manager in performing quality assurance and qualification audits on vendors/suppliers.
Support the Quality Control team during peak periods or absences.
Examine, measure, and test products and materials for defects or deviations from manufacturer or industry specifications. Inspect materials per specifications for workmanship, dimensions, tolerances, and usability.
Maintain daily records of inspection activities. Record inspection results. Keeps accurate and detailed records of material inspections.
Must be able to accurately read and comprehend documentation relating to material/production.
Responsible for compliance to LightScalpel’s Quality Management System and other regulatory and statutory requirements as required by local and international regulatory authorities.
Contribute to maintaining a safe work environment by following safety policies and procedures and by reporting any safety concerns.
Required Education, Skills and Experience:
High school diploma or general education degree (GED)
Minimum of 1-3 years of experience in quality control or quality assurance, preferably in the medical device industry. Strong organizational and follow-up skills, excellent attention to detail.
Basic knowledge of electronic components and computer skills.
Familiarity with quality tools and methodologies
Basic knowledge of quality management systems (QMS) and regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
Work Environment and Physical Demands:
Work is performed in a combination of warehouse and office environments. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, as well as inspection aids.
Position Type/Hours of Work:
This is a full-time position. Hours of work are Monday through Friday, 40 hours a week. Some overtime may be required occasionally.
Salary Range: $24 – $30 an hour. Offers are determined on a case-by-case basis considering multiple factors including job-related knowledge and skills, education, and experience.
Benefits include medical, dental and vision insurance, life insurance, short- and long-term disability insurance, 7 paid holidays plus 2 floating holidays, paid time off starting at 16 days per year, birthday leave, and participation to the company’s SIMPLE IRA retirement plan with matching employer contribution.
Who We Are:
LightScalpel’s laser engineers have over 300 years of combined technical expertise in the industrial and medical carbon dioxide laser industries. Our mission is to provide surgeons with the highest quality, state-of-the-art, precise, reliable, and affordable surgical carbon dioxide laser solutions. To learn more, please visit: www.lightscalpel.com
EEO Statement:
LightScalpel is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Job Type: Full-time
Pay: $24.00 – $30.00 per hour
Benefits:
Dental insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Retirement plan
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Work Location: In person
Title: Quality Assurance Officer at MIT spin-off medical device startup
Company: PASCALL SYSTEMS INC.
Location: Boston, MA
