Amplitude Vascular Systems
Quality Control Inspector
Amplitude Vascular Systems, Waltham, Massachusetts, United States, 02254
Overview
Join our dynamic R&D team as a
Quality Control Inspector . In this role, you’ll play a critical role in ensuring that our Pulse IVL System product meets established quality standards and specifications at various points in the organization while advocating for strict adherence to compliance practices within the facility. Key Responsibilities
With minimal supervision, performs incoming, in-process, and final inspections of components and finished device. Interprets quality inspection documents and deciphers quality expectations for the product. Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work. Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately. Performs and documents results of inspections per company procedures. Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed. Review and verify documentation for compliance with specifications and regulatory requirements (e.g., FDA, ISO 13485). Maintain accurate inspection records and support traceability and documentation control. Collaborate with engineering and manufacturing teams to identify and resolve quality issues. Assist in root cause analysis and corrective/preventive actions (CAPA). Support internal audits and regulatory inspections. Ensure calibration and maintenance of inspection tools and equipment. Required Qualifications
Associate or bachelor’s degree in business, supply chain, life sciences or other scientific field or equivalent work experience (3-5 years). 3+ years of experience in quality inspection in the medical device industry. Strong understanding of quality systems and regulatory standards (ISO 13485, FDA 21 CFR Part 820). Proficiency in using inspection tools (calipers, micrometers, gauges, vision systems) and reading technical drawings/specifications. Excellent attention to detail and documentation skills. Ability to work independently and as part of a cross-functional team. Strong communication and problem-solving skills. Experience with electronic documentation systems (e.g., eQMS). Familiarity with cleanroom protocols and GMP practices. ASQ certification (e.g., CQI) is a plus. Two (2) or more years of laboratory experience. Experience in QC inspection, cleanroom manufacturing, and medical device start-up. 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations. Understanding of a quality management system (QMS) and cGMP knowledge. Proficient level with Microsoft Office (Outlook, Excel, PowerPoint, and Word). Knowledge of Non-Conformance Reports (NCRs). Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Amplitude Vascular Systems by 2x. Inferred from the description for this job
Medical insurance Vision insurance 401(k) Paid maternity leave Disability insurance Get notified about new Quality Control Inspector jobs in
Waltham, MA . Methuen, MA $120,000 - $150,000 2 weeks ago Andover, MA $124,000 - $250,000 6 days ago Marlborough, MA $118,000.00 - $160,000.00 1 week ago Lexington, MA $80,000.00 - $82,000.00 2 days ago Boston, MA $125,000.00 - $145,000.00 2 weeks ago Quality Manager/Senior Quality Engineer (AEROSPACE/DEFENSE) Manager, Upstream Manufacturing - Drug Substance (7am to 7pm) Bedford, MA $123,100.00 - $152,000.00 1 day ago Westwood, MA $120,000.00 - $130,000.00 6 days ago Franklin, MA $130,000.00 - $140,000.00 1 month ago Quality Manager / Machine Shop $130K/yr. (Direct hire) Beverly, MA $100,000.00 - $115,000.00 1 month ago Westborough, MA $110,000.00 - $140,000.00 16 hours ago Senior Manager, Quality and Regulatory - MA - On Site Quality Manager - New Product Development Associate Director-Quality (Aerospace & Defense) Mansfield, MA $121,000 - $150,000 3 weeks ago Billerica, MA $109,000 - $121,000 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Join our dynamic R&D team as a
Quality Control Inspector . In this role, you’ll play a critical role in ensuring that our Pulse IVL System product meets established quality standards and specifications at various points in the organization while advocating for strict adherence to compliance practices within the facility. Key Responsibilities
With minimal supervision, performs incoming, in-process, and final inspections of components and finished device. Interprets quality inspection documents and deciphers quality expectations for the product. Approves products by confirming specifications, conducting visual and measurement tests, returning products for re-work and confirming re-work. Monitors use of equipment to ensure it is calibrated before use; keeps measurement equipment operating accurately. Performs and documents results of inspections per company procedures. Responsible for initiating non-conformance reports and ensuring non-conforming material is processed in accordance with the disposition. May assist with nonconformance investigations as needed. Review and verify documentation for compliance with specifications and regulatory requirements (e.g., FDA, ISO 13485). Maintain accurate inspection records and support traceability and documentation control. Collaborate with engineering and manufacturing teams to identify and resolve quality issues. Assist in root cause analysis and corrective/preventive actions (CAPA). Support internal audits and regulatory inspections. Ensure calibration and maintenance of inspection tools and equipment. Required Qualifications
Associate or bachelor’s degree in business, supply chain, life sciences or other scientific field or equivalent work experience (3-5 years). 3+ years of experience in quality inspection in the medical device industry. Strong understanding of quality systems and regulatory standards (ISO 13485, FDA 21 CFR Part 820). Proficiency in using inspection tools (calipers, micrometers, gauges, vision systems) and reading technical drawings/specifications. Excellent attention to detail and documentation skills. Ability to work independently and as part of a cross-functional team. Strong communication and problem-solving skills. Experience with electronic documentation systems (e.g., eQMS). Familiarity with cleanroom protocols and GMP practices. ASQ certification (e.g., CQI) is a plus. Two (2) or more years of laboratory experience. Experience in QC inspection, cleanroom manufacturing, and medical device start-up. 3+ year of Quality Control Experience in Medical Device Manufacturing. Knowledge of clean room operations. Understanding of a quality management system (QMS) and cGMP knowledge. Proficient level with Microsoft Office (Outlook, Excel, PowerPoint, and Word). Knowledge of Non-Conformance Reports (NCRs). Seniority level
Associate Employment type
Full-time Job function
Quality Assurance Industries: Medical Equipment Manufacturing Referrals increase your chances of interviewing at Amplitude Vascular Systems by 2x. Inferred from the description for this job
Medical insurance Vision insurance 401(k) Paid maternity leave Disability insurance Get notified about new Quality Control Inspector jobs in
Waltham, MA . Methuen, MA $120,000 - $150,000 2 weeks ago Andover, MA $124,000 - $250,000 6 days ago Marlborough, MA $118,000.00 - $160,000.00 1 week ago Lexington, MA $80,000.00 - $82,000.00 2 days ago Boston, MA $125,000.00 - $145,000.00 2 weeks ago Quality Manager/Senior Quality Engineer (AEROSPACE/DEFENSE) Manager, Upstream Manufacturing - Drug Substance (7am to 7pm) Bedford, MA $123,100.00 - $152,000.00 1 day ago Westwood, MA $120,000.00 - $130,000.00 6 days ago Franklin, MA $130,000.00 - $140,000.00 1 month ago Quality Manager / Machine Shop $130K/yr. (Direct hire) Beverly, MA $100,000.00 - $115,000.00 1 month ago Westborough, MA $110,000.00 - $140,000.00 16 hours ago Senior Manager, Quality and Regulatory - MA - On Site Quality Manager - New Product Development Associate Director-Quality (Aerospace & Defense) Mansfield, MA $121,000 - $150,000 3 weeks ago Billerica, MA $109,000 - $121,000 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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