Sr. Quality Engineer - Disposables

Belmont Medical Technologies is an exciting Medical Technology company that develops reliable fluid management, temperature management, and critical care medical devices for global use in medical facilities, military combat fields, and EMS settings. The company provides innovative products with unique features that have the capability to save thousands of lives. Cleanroom quality engineering experience with a medical device manufacturing company is required for this position. Sr. Quality Engineer -

Disposables:

Develop an expert knowledge of regulatory standards and regulations applicable to Belmont disposable devices. Work cross-functionally with Quality Control, Engineering, and Operations. Assist in developing and executing processes/tooling validation activities, lead process failure mode and effect analysis. Review proposed product changes, determine the need for requalification of products, components and tooling. Assist in reviewing and auditing QC function(s) to ensure quality products, compliance with Good Manufacturing Practices and all applicable quality system requirements. Monitor and trend environmental monitoring data for clean room and sterilization processes. Act as a quality representative of Material Review Board (MRB) to review nonconformances for disposable products. Investigate or assist with investigation of product failures initiated in manufacturing or reported by customer via the complaint process. Trend data for nonconformances and report top quality trends and issues to management. Perform internal audits and participate in Management Reviews . Responsible for assigned corrective and preventive actions to ensure effectiveness by adequate root cause investigation and timely completion. Assist in external audits and inspections, including Notified Bodies and Food and Drug Administration. Prepare training material and conduct training. Mentor other quality employees Perform other duties as assigned.

Required Skills and Qualifications:

Requires a Bachelor of Science Degree and 10+ years of experience in quality assurance and quality control in the medical device industry. Requires strong knowledge of domestic and international requirements applicable to the manufacturing of medical devices. In depth knowledge of biocompatibility, sterilization processes, clean room environment and regulatory requirements applicable to those processes. Requires strong communication skills, project management skills and high attention to detail. It is the policy of Belmont Medical Technologies to provide equal employment opportunities without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.

Job Type:

Full-time Pay:

$120,000.00 - $145,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Health savings account Life insurance Paid time off Referral program Tuition reimbursement Vision insurance

Experience:

biocompatibility/sterilization/cleanroom: 6 years (Preferred) Quality engineering: 8 years (Preferred) medical device industry: 6 years (Preferred)

Work Location:

In person