QC Inspector II

QC Inspector II Spectra Medical Devices, LLC Wilmington, Massachusetts, United States About this position About Elevaris Medical Devices Tired of working at a \" good\" job? At Elevaris, our goal is not to be good, it's to be extraordinary. Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field. Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies. POSITION SUMMARY The desired candidate will have prior Quality Inspector experience, preferable working in a medical device company. Specific experience and responsibilities will include, but not limited to performing incoming mechanical inspections, various functional testing, final inspections and support of 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 i.e. (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 temperature logging program with data collection and review of information MINIMUM REQUIREMENTS: High School Diploma or equivalent 2+ yrs. in a similar quality inspection role PREFERRED SKILLSET: 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. An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company 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 enable them to complete the application process. About Elevaris Medical Devices Tired of working at a \" good\" job? At Elevaris, our goal is not to be good, it's to be extraordinary. Extraordinary performance comes from extraordinary people. And the foundation for extraordinary people is extraordinary culture. Our values describe the behaviors that define our unique culture. They are what set us apart and what makes us trusted leaders in our field. Elevaris Medical Devices is leveraging a legacy of trust and expertise to usher in a new era of precision medical device development and manufacturing capabilities. We are development and engineering experts focused on delivering precision solutions to our medical device customers. Elevaris Medical Devices is one of the world's leading manufacturers of made-to-spec procedural needles. Beyond needles, we are also a Contract Development and Manufacturing Organization (CDMO) to industry-leading, multi-national healthcare companies, global original equipment manufacturers (OEMs), and emerging technology companies. We also distribute a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies. POSITION SUMMARY The desired candidate will have prior Quality Inspector experience, preferably working in a medical device company. Specific experience and responsibilities will include, but not limited to performing incoming mechanical inspections, various functional testing, final inspections and support of 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 i.e. (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 equipment PM program Support the temperature logging program with data collection and review of information MINIMUM REQUIREMENTS: High School Diploma or equivalent 2+ yrs. 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. An Equal Opportunity Employer/Contractor: Elevaris believes that all persons are entitled to equal employment opportunity. The Company 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 enable them to complete the application process. The pay range for this role is: 26.93 - 28.85 USD per hour(Wilmington) #J-18808-Ljbffr