Quality Manager

Description

Since 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT’s steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe.

Position Summary

This person will be involved with coordinating and managing the Quality Assurance activities in all areas of the production/manufacturing processes. This will consist of ensuring quality standards are met in the manufacturing of products. This person must be able to effectively communicate vital information to various personnel throughout the organization.

Duties And Responsibilities

This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties are required and/or assigned.

• Assist in troubleshooting raw material issues. Determine the best course of action to resolve these issues and create and distribute reports to the appropriate personnel
• Interpret and communicate company policies to governmental and third party auditors and enforce safety regulations
• Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
• Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.
• Prepare and submit of regulatory filings, including FDA 510(k) premarket notifications and product listings.
• Investigate complaints.
• Review and approve complaint reports.
• Analyze incoming complaints for reportability.
• Notify proper authorities as required.
• Track and trend complaints.
• Create and present complaint report two times each year.
• Review ECOs to ensure they are compliant and determine if regulatory bodies need to be notified of changes.
• Review QMS changes to ensure they do not disrupt the safety or performance of the medical device under control of our QMS and that it does not disrupt the safety and effectiveness of the QMS or compliance with regulatory requirements.
• Review and approve Engineering Test Protocols and Reports
• Manage complaints, testing, calibration and training.
• Train employees on changes to QMS.
• Facilitate external audits.
• Review employees providing input on their strengths and areas for improvement.
  
  

Requirements

Minimum Qualifications:

• Four Year Engineering degree
• 1-5 years related experience in a regulated environment, preferably medical device
• Proficiency with MS Office
• Familiarity with use of mechanical and electrical test equipment
• Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
• Ability to analyze and aggregate data using statistics
• Experience preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
  
  

Language Skills

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, vendors, non-engineers and the general public.

Mathematical Skills

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Certificates, Licenses, Registrations: Maintains a valid Driver’s License.

Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.

• Mental: Must be able to effectively communicate with others; complete and understand complex analysis of numbers; read, analyze and interpret written materials; develop team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.
• Physical: Must be able to hear and verbally communicate for hours at a time, use computer equipment, potentially operate a Lathe, Mill and/or electrical/general hand tools. Moderate noise level and limited exposure to physical risk.
  
  

Knowledge, Skills, and Abilities Required: Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.

Equipment Used: Telephones, computer, other office equipment as needed, electrical and general hand tools

Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, credit, and/or criminal background check.

AMT is an Equal Opportunity/Affirmative Action Employer.

Benefits

• Insurance: AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service.
• Other Benefits: AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others.
• 401k: AMT matches 100% of your contribution, up to 3% of your salary.
• Paid Time Off (PTO): In addition to nine paid holidays, AMT provides employees with paid time off (determined by length of service), starting on day one
  
  

Other Exciting Perks!

• Family-oriented, Positive Working Environment
• Discretionary Yearly Raises
• On-site Vending & Gym
• Annual Employee Appreciation Picnic
• Tuition Reimbursement
• Employee Referral Bonus Program
• Employee Assistance Program