QC Inspector II

QC Inspector II Spectra Medical Devices, LLC - Wilmington, Massachusetts, United States About Elevaris Medical Devices is a leading manufacturer of precision medical device solutions, focusing on procedural needles and associated equipment. We are a contract development and manufacturing organization with a commitment to quality and innovation. Position Summary The role requires prior Quality Inspector experience, particularly within medical device manufacturing. Responsibilities include performing incoming mechanical inspections, various functional testing, final inspections, and supporting calibration and equipment programs. Essential Functions / Major Responsibilities Perform incoming mechanical inspection on a variety of medical devices including custom needle assemblies, stainless steel surgical instruments, scalpel blades, glass LOR syringes, trocars, etc. Interpret engineering drawings and blueprints to determine inspection points and required product specifications. Use a variety of instruments for visual, dimensional, functional, and destructive testing (micrometer, caliper, video measuring equipment, Lloyd materials tester, pin gages, etc.). Conduct a variety of functional testing (pull, peel, burst, penetration). Generate Certificates of Conformance for accepted material prior to release of product. Perform final inspection on packaged material ready to be shipped by confirming shipping documentation and product labeling. Release material from Pending QA Inspection location to packaging area once the material has been inspected, accepted, and a COC has been generated. Support the calibration program. Support the equipment PM program. Support the temperature logging program with data collection and review of information. Minimum Requirements High School Diploma or equivalent. 2+ years in a similar quality inspection role. Preferred Skillset Prior medical device experience a plus. Knowledge of FDA Quality System requirements and ISO 13485 requirements a plus. Excellent organizational, verbal, written communication, and problem‑solving skills. Possess above‑average interpersonal skills demonstrating the ability to work with others in a professional, positive, and collaborative manner. Ability to work in a fast‑paced environment and to meet tight deadlines. Willingness to learn, possess a can‑do attitude, and motivated to succeed and grow. Ability to multi‑task with strong attention to detail. Proficient in MS Office Suite and of Statistical Process Control practices. Physical Demands & ADA Statement The physical demands described within the Essential Functions section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers, co‑workers, and external partners. Contact your manager or HR to understand the work conditions and physical requirements that may be specific to your role. Equal Opportunity Employer Statement Elevaris is an Equal Opportunity Employer/Contractor. We believe that all persons are entitled to equal employment opportunity and will not discriminate or tolerate discrimination against any employee or applicant because of race, color, creed, religion, genetic information, sex, sexual orientation, national origin, age, status with regard to public assistance, marital or veteran status, disability or any other characteristic protected by local, state or federal law. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall, and termination. Disabled applicants may request any reasonable accommodation needed to complete the application process. Pay Range $26.93 - $28.85 USD per hour (Wilmington). #J-18808-Ljbffr