R&D Quality Inspector III

2 months ago


Minneapolis, United States VitalPath Full time
Job DescriptionJob Description

Join VitalPath in New Hope as an R&D Quality Inspector III

About VitalPath

VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team

About the Position

Under little supervision perform product and raw material inspection using inspection tools and methodologies. Support and coordinate daily and final quality assurance workflow, while ensuring all documentation is complete and accurate. This position supports prototype, design and development, clinical, and pre-production manufacturing.

Responsibilities

  • Perform visual, dimensional, and functional inspection per product requirements to assure quality standards and specifications are met
  • Perform incoming inspections of materials and purchased items. Including visual, dimensional, and functional inspections on consumables, subassemblies, raw materials, and fixtures
  • Execute First Article Inspections
  • Assist with or perform test method validations
  • Partner with engineers on new product development
  • Work inside a controlled environment
  • Interface with ERP software, eQMS software, and Microsoft (Outlook, Word, Excel) regularly
  • Read, analyze, and interpret documents such as policies, procedures, drawings, product specifications, receiving inspection plans, test procedures, and other materials related to the position
  • Use verbal and written communication to exchange information required to complete essential duties and responsibilities
  • Handle and use typical quality inspection equipment including microscope, video measuring system, toolmakers scope, force testers, pin gages, drop gages, calipers, rulers, laser micrometer, and other tools or methods
  • Recognize quality issues and communicate with management
  • Identify product and/or documentation nonconformances and escalate to management
  • Identify, segregate, and manage nonconforming material
  • Initiate, perform, and complete product disposition for nonconforming material
  • Accurately document all work performed on inspection reports and travelers
  • Verify completeness and accuracy of device history records to ensure good documentation practices are performed
  • Resolve job related issues promptly in a manner that promotes harmony and aligns with the company’s objectives and goals
  • Ensures equipment is calibrated and within tolerance
  • Support in-house calibration efforts
  • Follow and support good manufacturing practices (cGMP) and good documentation practices (GDP)
  • Maintain a clean, organized, and safe work area
  • Complete and file production and quality documentation
  • May train peers in quality inspection
  • May provide recommendation or suggestion on continuous improvement
  • May perform other duties as determined or assigned by management

Requirements

  • 5 years or more of quality inspection experience (Quality Inspection, Quality Testing, and Receipt of Materials) in the medical device industry; experience working in a regulated environment (FDA, GMP, ISO, etc)
  • Thorough knowledge of quality control standards and testing methodologies
  • Knowledge of and ability to use inspection tools such as rulers, calipers, gauges, micrometers, height gauges, thread gauges, and comparator or vision system
  • Understand and utilize Acceptance Sampling Plans using AQL sampling and 100% inspection
  • Knowledge of clean room operations
  • Customer focused
  • Results-oriented and displays high energy and enthusiasm (Sense of Urgency)
  • Knowledge of cGMP and GDP; able to provide coaching
  • Displays integrity, ethics, and trust
  • Holds themselves and others accountable
  • Effective team collaboration skills. Must exhibit willingness to work in teams, promote teamwork among other employees and communicate effectively with a variety of people
  • Excellent attention to detail, including spotting product or material nonconformity
  • Highly focused, organized, and detailed oriented
  • Possess intermediate math skills: addition, subtraction, multiplication, division, weights, and measures.
  • Demonstrated ability to read, write, and speak English with the ability to follow written instructions or procedures
  • Proficiency with computers, including Microsoft Office
  • Strong verbal and written communication skills
  • Demonstrated ability to interpret dimensional requirements on drawings and specifications

Preferred

  • eQMS and ERP Experience
  • Highly motivated and positive individual that can work both independently and in a cross-functional team environment
  • Develop and foster teamwork and a positive working environment, while reducing work area distraction
  • Strong organizational and follow-up skills
  • Multitasks, prioritizes, and meets deadlines in a timely manner
  • Strong training abilities
  • Ability to influence others to follow rules and regulations

Benefits

  • Comprehensive, Low Cost Health and Dental Insurance Plans Available
  • Vision Insurance
  • Health Savings Account with company contribution
  • Short and Long Term Disability
  • Supplemental insurances (short term disability, AD&D, life insurance, and more)
  • Paid Time Off
  • Sick Time Off
  • Paid Holidays
  • 401K with company match
  • Competitive compensation
  • Opportunities for career growth and advancement

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.

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