KARL STORZ North America · 18 hours ago
Quality Inspector III, 2nd
Charlton, MA
Full-time
Onsite
Mid Level
3+ years expKARL STORZ North America is a company focused on manufacturing high-quality medical devices. They are seeking a Quality Inspector III responsible for verifying both purchased and in-house manufactured products to ensure they meet required standards through various inspection and testing functions.
Medical Device
Responsibilities
Perform moderately difficult inspection and functional test of components, sub-assemblies and finished devices in accordance with established procedures
Familiar with required documentation (blueprints, procedures and test/inspection plans)
Understand and direct focus to priorities within the inspection department, with little or no supervision. Able to act as a team lead as required
Understand, teach, support and lead by example lean principles
Understand, teach, support and lead by example 6S principles
Perform audits as necessary for the job function
Cross trained in all areas of inspection, including incoming inspection, Fiberscope Final Inspection, and Videoscope Final QC Inspection
Perform training in the aforementioned areas, to procedures and SAP transactions, as required
Perform calibrations and preventive maintenance activities for equipment assigned to the QA department
Maintenance of inspection logs, worksheets and device history records
Perform material transactions and other SAP transactions as required. Assist in trouble shooting activities, as related to department transactions and cycle counts
Perform final labeling and packaging of Finished Goods
Perform data entry of QC Inspection results using Excel and SAP
Ensure Good Documentation Practice of all controlled records
Perform archiving activities for digital storage of controlled records
Accountable for final release of product to shipment
Qualification
Required
High school graduate or equivalent
3 – 5 years' experience in Quality Control or in a manufacturing role where quality is essential to the product
Ability to read and interpret engineering drawings, procedures and sampling plans
Knowledgeable in the Lean process
Ability to lead in both 6S and CI (EOED) efforts
Proficient in various inspection techniques, including visual inspection (using a microscope), performing variable and attribute mechanical/dimensional measurements, optics inspection and electronic/safety testing desired
Knowledgeable of fiber and video endoscopes and can make pass/fail decisions independently
Knowledgeable in the FDA and ISO Quality Systems requirements
Process time at or below takt time consistently
Experience with computer data entry
Experience completing various ERP transactions such as SAP
Must be able to work overtime as needed
Must be punctual, able to sustain attendance guidelines, and work hours as assigned
Regular and predictable attendance and proper notification/communication in the event of absence or tardiness
Moderate lifting of objects up to 50lbs. Lifting up to 70lbs. (with assistance) may be required on occasion
Some inspection functions may require standing for extended periods of time
Some inspection functions may require viewing under microscope for long periods of time
Visual acuity of 20/25 in the better eye with or without correction in order to make judgments on visual quality of optical and other devices
Capable of making accept/reject decisions based on both established procedural criteria and subjective criteria and of explaining these decisions to other inspection personnel or other contacts (other departments, engineers, etc.), as required
Able to communicate, in both written and verbal format, clearly and concisely with personnel at all levels of the organization
Must be able to recognize and bring to supervisory attention, situations that may impact quality, but which are not covered in established procedures
Must be capable of making suggestions to aid in the solution of various workflow situations and process improvements
The ability to recognize and bring to supervisory attention near miss and ergonomic issues that may impact the department or company as a whole
Perform moderately difficult inspection and functional test of components, sub-assemblies and finished devices in accordance with established procedures
Familiar with required documentation (blueprints, procedures and test/inspection plans)
Understand and direct focus to priorities within the inspection department, with little or no supervision. Able to act as a team lead as required
Understand, teach, support and lead by example lean principles
Understand, teach, support and lead by example 6S principles
Perform audits as necessary for the job function
Cross trained in all areas of inspection, including incoming inspection, Fiberscope Final Inspection, and Videoscope Final QC Inspection
Perform training in the aforementioned areas, to procedures and SAP transactions, as required
Perform calibrations and preventive maintenance activities for equipment assigned to the QA department
Maintenance of inspection logs, worksheets and device history records
Perform material transactions and other SAP transactions as required. Assist in trouble shooting activities, as related to department transactions and cycle counts
Perform final labeling and packaging of Finished Goods
Perform data entry of QC Inspection results using Excel and SAP
Ensure Good Documentation Practice of all controlled records
Perform archiving activities for digital storage of controlled records
Accountable for final release of product to shipment
Must be committed to a high standard of safety and be willing and able to comply with all environmental and safety laws and regulations, including the Company's environmental and safety policies and procedures
The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001
Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others
Responsible for informing the Company if he/she is taking medications or if there are any other circumstances that would interfere with safe performance of job duties
The incumbent in this position is responsible for knowledge of and adherence to the policies and procedures as they relate to the requirements of FDA Quality System Regulation, and ISO 13485
Must be able to maintain productive working relationships with co-workers
Must treat fellow employees with respect
Able to escalate atypical non-conformances to management
Able to communicate, in both written and verbal format, clearly and concisely with personnel at all levels of the organization and on occasion, with external customers and suppliers
Must be adaptable and demonstrate flexibility in dealing with changing priorities and work situations
Preferred
Previous experience with medical devices and QSR/ISO requirements desirable
Certified Shift Trainer preferred
Company
KARL STORZ North America
KARL STORZ North America is a leader in endoscopic technology and imaging solutions across virtually all surgical specialties.
1001-5000 employees
H1B Sponsorship
KARL STORZ North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (10)
2023 (14)
2022 (6)
2021 (8)
2020 (10)
Funding
Current Stage
Late StageLeadership Team
Bethany Kucera
Senior Human Resources Business Partner
Eric Allen, SHRM-CP
Human Resources Business Partner
Company data provided by crunchbase