Incoming Quality Inspector Job in Burlington 01803, Massachusetts Us

ConforMIS, Inc. is a privately held medical device company based in Burlington, Massachusetts. It was founded in 2004 to provide dramatic advancements in patient care by utilizing imaging technology to create personalized, patient-specific implants and instrumentation.

Job Summary:

This position is responsible for quality inspection /quality assurance activities. This includes interpretation and implementation of quality standards to routine inspection/testing and manufacturing activities.

Essential Duties and Responsibilities:

• Inspect incoming, in-process, finished parts, and materials for conformance to quality control standards.
• Must be able to perform 100% inspections on First Articles and final inspections.
• Initiate and participate in resolution of non-conformance reports (NCMR’s).
• Internal auditing
• DCO generation
• Knowledge of tool calibration and tracking of tools
• Administration of various Quality system elements; NCMR log, etc.
• Conduct incoming, in-process and final product inspections per company procedures
• Inspect, sample and perform physical/visual inspections on components per standard procedures
• Segregate / control non-conforming materials
• Maintain inspection files
• Review and maintain Device History Records
• Responsible for final product release sign-off
• Identify potential non-compliances/improvements in the inspection/manufacturing area and initiate document change orders as required
• Other duties as assigned

Qualifications:

• HS Diploma, Associates degree preferred or equivalent work experience
• 3+ years’ experience performing inspection within a FDA or other regulated environment
• Proficient in Word and Excel
• Thorough understanding of cGMP, ISO 13485
• Ability to read and interpret engineering drawings
• Oracle experience a plus
• GDT certification a plus

Skills, Abilities, Competencies Required:

• 20/20 vision required with our without corrective lenses
• Manual dexterity to handle tools and equipment of different sizes
• Proficient in the use of hand measuring tools such as calipers, micrometers, dial indicators, etc.
• Willingness and ability to embrace new inspection tools and methodology
• Ability to multi-task, perform efficiently, and independently
• Excellent English communication skills; written and verbal
• Contribute towards continuous improvement with regards to Quality, efficiency, and customer focused results
• Must be able to work in a team environment, execute responsibilities with minimal direct supervision, and have a high attention to detail
• Operate and program CMM desirable
• Operate Optical Comparator desirable
• Statistical Process Control desirable
• Advanced knowledge of inspection/metrology desirable

Working conditions:

• Standing and sitting for extended periods
• Lifting up to 20 pounds
• Busy work environment with frequent interruptions
• Working overtime and and/or a flexible schedule as needed
• Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies
• Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.).

Shifts Available:

6:00 am to 2:30 pm or 2:00 pm to 10:30 pm

ConforMIS, Inc. is an Equal Opportunity Employer