Lead Quality Assurance Inspector
About The Position
As a ProMed employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best. ProMed was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world. Working as one to help many. The Quality Assurance Inspector is responsible for ensuring that products meet a set of standards. The Quality Assurance Inspector performs assessment, documentation and organization tasks to support the efficiency and effectiveness of ProMed’s supply chain. The Quality Assurance Inspector ensures ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.
Requirements
- High School diploma or general education diploma
- Minimum of 2-3 years of quality experience preferred
- Quality background with ALCOA++ Principles
- Experience/familiarity with eQMS and ERP systems
- Must be able to read, analyze, and interpret documents related to the job and projects such as SOP’s and work instructions
- Ability to train new Inspectors
- Experience working in cleanroom environment
- Knowledge of quality events (deviations, investigations, non-conforming events, CAPAs)
- Excellent communication and interpersonal skills both written and verbal; professional, courteous and friendly personality; clearly conveys ideas and information and receives information effectively
- Excellent organizational, problem-solving, critical thinking and time-sensitive skills
- Ability to create positive working relationships with a diverse group of people including gender, ethnicity, age, and cultural and skill level differences
- Ability to work independently with minimal supervision
- Ability to establish priorities and meet deadlines
Nice To Haves
- Commitment to continuous improvement company-wide
- Knowledge and/or training to 21 CFR 210/211 and ISO 13485 (current) standards
- Fluent in reading and writing English
Responsibilities
- Performs microscopic, visual and dimensional inspection of manufactured parts using related measuring equipment
- Performs line clearance and QA checks as needed
- Assist with QA operations such as inspection, issuing deviations, processing NCMRs, etc
- Assists research and development projects, as needed
- Assist with batch record review according to established procedures
- Assists with QA product release tasks
- Reviews incoming receipt for all materials
- Monitors the production line to ensure adherence to standards and procedures
- Supports the maintenance of other quality functions such as audits, quality events, documentation control
- Demonstrates a high degree of organization, accuracy, thoroughness and efficiency
- Any other duties and tasks as deemed necessary and appropriate.
Benefits
- 401k with company match
- Profit Sharing Program
- Medical Insurance
- Health Savings Account/Flexible Spending Account
- Dental Insurance
- Vision Insurance
- Life Insurance
- Paid Family Medical Leave and Long-Term Disability Insurance
- Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection
- Pet Insurance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
