Quality Assurance Engineer jobs in Lansing, MI

Quality Assurance Engineer performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products. Assists in developing quality control policies and evaluates production limitations. Being a Quality Assurance Engineer requires a bachelor's degree. Typically reports to a supervisor or manager. To be a Quality Assurance Engineer typically requires 0-2 years of related experience. Works on projects/matters of limited complexity in a support role. Work is closely managed. (Copyright 2024 Salary.com)

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Senior Quality Assurance Specialist / Engineer
  • Niowave Inc.
  • Lansing, MI FULL_TIME
  • Senior Quality Assurance Specialist / Engineer
    Who we are…
    We are a group of scientists, engineers, designers, technicians, and many others who are dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We also enjoy darts, cornhole, ping-pong, take-out for group lunches, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.
     
    Why patients need you…
    Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to our partners and patients. Our science and risk-based compliant quality culture is innovative and partner oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
     
    Who you are…
    You have a precise nature and embrace attention to detail. You value established procedures to ensure first-time quality for accurate and on-time results. Words that describe you are consistent, efficient, diligent and technologically savvy.  You also embrace change to keep pace with emerging information and shifting priorities, offering suggestions to improve process flows.  You get great satisfaction from launching new products, improving compliance on existing products or procedures and rise to the occasion to take on miscellaneous projects. You easily transition between working independently to working with a team with excellent customer service as your internal guide. 
     
    What you can expect to work on…
    You’ll provide instrumental support within the quality team and throughout the company to ensure timely project and compliance support.
     
    What you need to succeed…
    Excellent communication and interpersonal skills – you know how to develop & maintain strong relationships with all levels/teams of the organization.  Understand how to integrate into a new team/organization – you appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.  Understand your own communication and learning styles, assess other styles, and are able to find the right path to connect the two.  Exceptional technology skills – you find working with any software very comfortable and you easily adapt to new products.
     
    What You Will Achieve…
    The Senior Quality Assurance Specialist (Engineer) ensures compliant manufacturing procedures, equipment, and facilities in our new manufacturing facility in adherence with cGMP requirements, Quality Standards, and other regulatory requirements. This position is part of a strong and growing team launching first of its kind products to accelerate the fight against cancer.
     
    Essential functions
    • Utilize advanced quality tools to drive improvements, encompassing process flowcharting, Pareto analysis, correlation and regression analysis, significance tests, design of experiments, statistical process control, gauge repeatability and reproducibility, and trend analysis techniques.
    • Monitor manufacturing processes and products, for adherence to both company and regulatory standards, and actively participate in quality improvement initiatives and projects.
    • Support quality reviews and audits (internal and external) by evaluating data, preparing reports to verify regulatory compliance, identifying deviations and recommending opportunities for improvement.
    • Lead and support validation of test methods, processes, and equipment by training quality and operations personnel.
    • Act as a customer liaison, managing customer quality complaints.
    • Lead and manage NPI quality activities including prototype testing, process validation, and technology transfer ensure successful product launches.
    • Provide support for IND/DMF/IMPD submissions, product registrations, facility registrations, and IND submissions to the FDA and customers as required.
    • Lead and support development of essential Quality System components, including complaint analysis, risk analysis, failure mode and effects analysis, NCMR, CAPA, complaints, and process/equipment/software verification/validation.
    • Lead and support change requests by working closely with production to document and standardize process parameters.
    • Lead and support pre- and post-production reviews, providing valuable quality and regulatory insights.
    • Lead or guide teams through NCMR, complaints, and CAPA.
    • Collaborate with cross-functional teams to solve production and quality challenges.
    • Drive quality and compliance, adhering to all Quality Systems documentation requirements and establishing/supporting plans to exceed Niowave's goals for Quality, including Safety, Compliance, Six Sigma Quality, On-Time Delivery (OTD), and financial objectives.
    • Monitor internal and external quality metrics and proactively resolve issues related to product characteristics, features, and associated documentation.
    • Lead and develop team members, nurturing a positive business culture that aligns with our values and leadership competencies.
    • Function as an independent Reviewer for team and coworkers throughout the team as needed to support continued training, guidance and ensure quality and regulatory.
    Competencies
    • Highly accountable, visionary leader with excellent management aptitude both in theory and application.
    • Excellent interpersonal, written, and oral communication skills.
    • Strong mechanical aptitude. 
    • Able to prioritize and execute tasks in a high-pressure environment.
    • Expertly performs in a team-oriented, collaborative environment.
    • Highly values integrity, professionalism, and confidentiality.
    • Embraces and models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal.
    • Understands how to integrate into a new team/organization – appreciates the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state.
    • Understands their own communication and learning styles, can assess others’ styles, and is able to find the right path to connect the two.
    Education and experience
    • Minimum of five (5) years’ experience in an FDA regulated industry, preferably in pharmaceuticals. Three (3) or more years in a Quality role, preferably Quality Assurance.
    • Bachelor’s degree in Sciences or Engineering (e.g., Chemical, Mechanical, Manufacturing, Industrial).
    • Engineering experience in both the Research/Development and Production environments.
    • Experience applying lean manufacturing principles and practices.
    Work Environment
    This job operates in a professional office environment. This role routinely uses standard office equipment.
     
    Physical Demands
    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
    While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 pounds.
     
    Position Type/Expected Hours of Work
    This is a full-time position. Days of work are typically Monday through Friday, 8 a.m. to 5 p.m. Production support on off shifts are weekends will be required as needed to ensure quality support is present.
     
    Travel
    Travel is primarily local during the business day between the company’s two locations.
     

  • 1 Month Ago

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Automotive Quality Engineer - Contract - Interior & Exterior
  • TRIGO Global Quality Solutions
  • Lansing, MI CONTRACTOR
  • Quality Engineer - Contract - Launch Support Lansing, MI 3 months open to non-local candidates Position: TRIGO Quality Solutions is looking for multiple Quality Engineers for immediate openings to sup...
  • 2 Days Ago

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Manager, Quality Assurance
  • Delta Dental of Michigan
  • Okemos, MI FULL_TIME
  • This is a hybrid position, both in-office and remote. Delta Dental of Michigan, Ohio, and Indiana is a leader in dental benefits, plus so much more. We improve oral health through benefit plans, advoc...
  • Just Posted

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Quality Assurance Analyst
  • Michigan Milk Producers Assoc
  • Ovid, MI FULL_TIME
  • Quality Assurance AnalystThe Michigan Milk Producers Association- MMPA is currently seeking a highly motivated individual for our fast-paced Quality Department, as a Quality Assurance Analyst in our O...
  • 5 Days Ago

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Transportation Engineer Licensed Specialist 13 (Road Scoping & Quality Assurance) University Region
  • State of Michigan
  • Jackson, MI FULL_TIME
  • POSTING MAY CLOSE AT ANY TIME ONCE THE POSTIION HAS BEEN FILLED.As the Road Scoping and Quality Assurance (QA) Engineer for the University Region, this position will serve as the technical expert and ...
  • 28 Days Ago

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Automotive Consultant - Electrical Engineer - Contract
  • TRIGO Global Quality Solutions
  • Lansing, MI CONTRACTOR
  • Electrical Engineer - Contract - Launch Support Lansing, MI 3 months Includes lodging, travel expenses and Per Diem Position: TRIGO Quality Solutions is looking for an Electrical Engineer for a 3 mont...
  • 20 Days Ago

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0 Quality Assurance Engineer jobs found in Lansing, MI area

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DYNAMICS 365 DEVELOPER
  • Integrated Resources, Inc ( IRI )
  • Lansing, MI
  • Title: Senior Programmer Analyst Location: Lansing, MI, United States (Hybrid Role with 2 days onsite from day 1 - Tuesd...
  • 4/24/2024 12:00:00 AM

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QA Automation Engineer - SDV
  • General Motors
  • Lansing, MI
  • Hybrid: This role is categorized as hybrid. This means the successful candidate is expected to report to Warren, MI thre...
  • 4/24/2024 12:00:00 AM

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Lead Software Engineer
  • Humana
  • Lansing, MI
  • Become a part of our caring community and help us put health firstDo you want be part of a team that is continuously lea...
  • 4/24/2024 12:00:00 AM

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Analyst, Audience Addressable
  • Comcast Corporation
  • Lansing, MI
  • Effectv helps businesses reach the right audience with the right message at the right time. We harness the scale and qua...
  • 4/23/2024 12:00:00 AM

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Dynamics Developer
  • Brooksource
  • Lansing, MI
  • Job Title: Software Developer (Microsoft Dynamics 365 CRM) Location: Lansing, MI Onsite Requirement: 2 day a week (Tuesd...
  • 4/22/2024 12:00:00 AM

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Programmer Analyst
  • Ageatia Global Solutions
  • Dimondale, MI
  • In the analyst role, the Programmer Analyst is responsible for gathering and documenting clear, unambiguous, and testabl...
  • 4/21/2024 12:00:00 AM

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System Analyst 6 - Test Manager
  • Tekfortune
  • Lansing, MI
  • Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for wo...
  • 4/20/2024 12:00:00 AM

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Quality Engineer
  • Venteon
  • Lansing, MI
  • This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assuranc...
  • 4/20/2024 12:00:00 AM

Lansing /ˈlænsɪŋ/ is the capital of the U.S. state of Michigan. It is mostly in Ingham County, although portions of the city extend west into Eaton County and north into Clinton County. The 2010 Census placed the city's population at 114,297, making it the fifth largest city in Michigan. The population of its Metropolitan Statistical Area (MSA) was 464,036, while the even larger Combined Statistical Area (CSA) population, which includes Shiawassee County, was 534,684. It was named the new state capital of Michigan in 1847, ten years after Michigan became a state. The Lansing metropolitan area,...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineer jobs
$64,921 to $80,583
Lansing, Michigan area prices
were up 1.3% from a year ago

Quality Assurance Engineer in Cleveland, OH
Technically supervises quality projects or major phases of significant quality projects, coordinating the efforts of technical support staff in the performance of assigned project.
November 16, 2019
Quality Assurance Engineer in Altoona, PA
SQA Engineers develop and execute software test plans in order to identify software problems and their causes.
November 08, 2019
Quality Assurance Engineer in Tulsa, OK
An entry level role, the degreed Engineer knows and applies basic concepts and techniques of the profession under direct supervision and guidance.
November 01, 2019