Quality Control/Quality Assurance Inspector II
Elliquence · BALDWIN, NY ·
- Category
- QA
- Experience
- 3+ years
- Salary
- USD 55,000 – 62,000 / year
Performs hands-on inspections and tests of medical devices using precision tools to verify dimensional, mechanical, and electrical compliance, documents defects, and supports corrective actions.
Quality Control/Quality Assurance Inspector II is responsible for monitoring and evaluating products or materials to ensure they meet established quality standards and specifications. This role will conduct inspections, tests, and measurements using specialized tools and techniques, and document any deviations or defects found during the process. In addition to identifying quality issues, they often assist in developing corrective actions and collaborate with production teams to improve processes. Their role is crucial in maintaining product consistency and compliance with regulatory requirements.
Core Duties & Responsibilities
1. Product Inspections & Testing
Cross-Functional Support
Qualifications:
Physical Requirements
This role is located on site in Baldwin, NY.
Salary Range. 55,000-62,000/annual.
An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].
Core Duties & Responsibilities
1. Product Inspections & Testing
- Verification/Testing: Perform verification and testing per testing protocols using precision instruments such as calipers, micrometers, and gauges to check for strict dimensional compliance.
- General Testing: Perform testing on various products in the company’s product line for mechanical and electrical testing.
- Incoming, In-Process, and Final Audits: Examine raw materials from suppliers, monitor products on the assembly line, and approve final goods prior to packaging and shipping.
- Compliance: Verify that all manufactured output adheres to company guidelines and strict industry regulations.
- Repairs: Perform repair verification on various products as required.
- Record Keeping: Prepare inspection reports, log daily defect rates, and input data directly into quality management software or databases.
- Non-Conformance: Initiate Nonconforming Material Reports (NCMRs) and properly isolate, label, or discard defective or failed components.
- First Article Inspection (FAI): Support the FAI process when introducing new parts or suppliers in conjunction with Engineering.
- Track and Monitor: Support the full lifecycle for Return Merchandise Authorization (RMA) including status tracking, proactive monitoring, and cross-function coordination where necessary to ensure a timely resolution.
- Return Material Authorization (RMA): Perform testing for any products with issues for verification in accordance with the testing protocols and able to interact with customer for timely solution and final outcome.
- Troubleshooting: Identify root causes for product defects and recommend adjustments to assembly or manufacturing processes.
- Corrective Actions: Assist engineering and quality teams by drafting and implementing Corrective Action Requests (CARs).
- Team Support: Train junior inspectors or assemblers in quality control standards and proper measuring techniques.
- Calibration: Ensure that all testing and lab equipment operates accurately by following routine operating instructions, performing preventive maintenance, and scheduling repairs.
Cross-Functional Support
- Provide guidance and support to cross-functional teams on Quality Department projects.
- Partner in continuous improvement initiatives in conjunction with the Engineering team
- Assist with special projects as needed.
Qualifications:
- High School Diploma or equivalent and/or Technical School completion with a minimum of 3 years of relevant manufacturing experience. Medical device industry experience a plus.
- Previous work experience in an ISO & MDR environment a plus.
- Proven ability to work independently and collaboratively, with a willingness to learn and take on new tasks.
- Ability to work with tools/instruments such as calipers, multimeters, force pull gauges, pin gauges, and block gauges.
- Working knowledge of Microsoft Office suite and Adobe. Experience in ERP a plus.
- Demonstrated experience performing in-process quality inspections, material disposition, and documentation review.
- Solid experience and able to perform with confidence supporting rework activities, and samples from suppliers.
- Demonstrated experience in continuous improvement initiatives, deviation identification, and collaboration with Production, R&D, and Quality teams.
- Strong ability to interpret and follow SOPs, NCR (Non-Conforming Report), and product specifications.
- Effective communication skills with the ability to escalate discrepancies and collaborate cross functionally within the organization.
- Strong attention to detail, commitment to excellence and time-management skills to ensure deadlines are upheld and competent coverage.
Physical Requirements
- Ability to independently up to lift 25 lbs.
- Prolonged periods sitting at a desk and working at a computer and performing product quality control initiatives.
- Must possess steady hands and strong finger dexterity to handle delicate components and operate precision measuring instruments.
This role is located on site in Baldwin, NY.
Salary Range. 55,000-62,000/annual.
An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].