Senior QA Inspector - Cleanroom Medical Devices

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.

POSITION SUMMARY

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.

ESSENTIAL DUTIES & RESPONSIBILITIES

Position duties and responsibilities include, but are not limited to the following: 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; Other Duties as Needed: Any other duties and tasks as deemed necessary and appropriate.

QUALIFICATION, EDUCATION & EXPERIENCE

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: 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-confirming 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. Preferred: 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.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the principal roles and responsibilities of this job. Exposure to heated/air conditioned, ventilated facilities with florescent lighting; Exposure to building where a variety of chemical substances are used for cleaning, and/or operation of equipment; The noise level in the work environment is usually minor; Duties are performed indoors; Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL, SENSORY, COGNITIVE & NEUROLOGICAL DEMANDS

While performing the duties of this job: The employee may be required to stoop, bend, squat, kneel, reach, stand, walk, lift, pull, push, grasp, talk, hear, see and use repetitive motions; Specific vision abilities required include close vision such as to read handwritten or typed material and the ability to adjust focus; The position requires the individual to meet multiple demands from several people and interact with internal and external people; Employee moves about the building and be able to maneuver in tight spaces between desks, etc.; Employee may have duties involving walking on even or uneven surfaces; Employee occasionally to frequently use a whiteboard, which can require grasping whiteboard pens, reaching at, below, or above shoulder height and may require trunk or neck rotation to look back; Employee may use computers, overhead projectors, TV, and other work-related equipment, which may require an approximately 25+ pound force to push or pull equipment; It is necessary to grasp and manipulate pens, markers, scissors, staplers, etc. occasionally to frequently. Employee must see and hear on a continuous basis as well as speak frequently; Position varies from standing, sitting, walking, etc. On some occasions it may be necessary to move quickly, run, etc. over smooth or uneven surfaces. ProMed offers a generous benefits package including: 401k with company match Profit Sharing Program Medical Insurance Health Savings Account/Flexible Spending Account Vision Insurance Life Insurance Paid Family Medical Leave and Long-Term Disability Insurance Hospital Indemnity, Critical Illness, Accident, and Identity Theft Protection Pet Insurance ProMed does not discriminate in employment opportunities or practices on the basis of race, color, creed, religion, national origin, ancestry, age, sex, marital status, order of protection, disability, military status, sexual orientation, gender identity, pregnancy, public assistance, family status, unfavorable discharge from military service, genetic information or other segmenting factor protected by law, or local human rights commission activity. #J-18808-Ljbffr PROMED MOLDED PRODUCTS INC