Lead Quality Assurance Inspector

• 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.

• High School diploma or general education diploma;
• Minimum of 2-3 years of quality experience preferred;
• Quality background with ALCOA++ Principles;

• 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.

• 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.

• 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.

• 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
• 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

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.