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Niowave
Lansing, MI | Full Time
$90k-108k (estimate)
2 Months Ago
Senior Quality Assurance Specialist / Engineer
Niowave Lansing, MI
$90k-108k (estimate)
Full Time 2 Months Ago
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Niowave is Hiring a Senior Quality Assurance Specialist / Engineer Near Lansing, MI

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.

Job Summary

JOB TYPE

Full Time

SALARY

$90k-108k (estimate)

POST DATE

03/09/2024

EXPIRATION DATE

07/09/2024

WEBSITE

niowaveinc.com

HEADQUARTERS

Lansing, MI

SIZE

50 - 100

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