Quality Assurance Scientist in South Bend

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Job DescriptionJob Description

Kulzer, one of the world’s leading dental companies for more than 90 years, is looking for an experienced Quality Assurance Scientist to join our Quality and Regulatory Department. In the role of Quality Assurance Scientist, you will be responsible to analyze raw materials, intermediates, and finished products following prescribed procedures on dental products. You will also facilitate creation of new products and ongoing controls for existing products.

What We Offer

Kulzer offers an exciting work environment with flexible work/life balance schedules, competitive salaries, and superior benefits. Featured benefits include:

• Fair and competitive pay
• Premium benefits package including health, dental, vision, and supplemental insurance plans.
• Health savings account
• 401k with 100% company match of up to 5% of your pay.
• Excellent paid time off
• 10 paid holidays
• Medical opt-out benefit.
• Company paid long term , short term and life insurance.
• Tuition reimbursement program
• Paid Training
• Wellness Program including employee assistance program, gym reimbursement, and more!
• Referral bonus program

What We Are Looking For

An experienced scientist with proven experience in analytical chemistry, preferably related to powder or solution testing and previous experience working with third-party standards and regulatory requirements as required. Interpret the results and recommend the type of disposition. Help perform troubleshooting and problem-solving experiments as required. Recommend changes in procedures based on experience and independent evaluations. Help develop and update specifications for raw materials and finished products.

Position Responsibilities Include:

• Evaluate and report test results in accordance with established procedures.
• Work with other analysts to solve problems of technique or equipment usage in performing assays to assure accuracy and validity of techniques and results.
• Perform experiments used in troubleshooting and problem solving related to the quality of product or methodology.
• Identify and implement statistically proven test methods.
• Conduct risk assessments, root cause analysis, and identify corrective actions.
• Conduct studies and report results using statistically proven techniques.
• Assist with Chemical Hygiene Officer (CHO) duties such as monitoring lab safety and compliance, monitor proper chemical labels, storage and segregation practices, and adhere to established safety programs.
• Assist or lead product improvement projects, meetings, vendor qualifications, reformulation, or complaint reviews.
• Maintain accurate Quality System procedures.
• Comply with external regulations, Quality System procedures, and company policies.
• Responsible to create and maintain accurate documentation.

Your Qualifications/Skills Should Include:

• Bachelor’s degree in chemistry
• Previous experience in quality science, preferably within a regulated or manufacturing environment.
• Prior experience in mixing and blending formulations is strongly
• Medical device experience is strongly .
• Direct quality science experience .
• Proven experience in analytical chemistry mandatory, preferably related to powder or solution testing
• Basic understanding of statistical techniques and automated data handling
• Experience working with various test methods and interpretation of results
• Proven experience with basic laboratory techniques
• Strong written, oral, and interpersonal communication skills
• Previous experience with technical analysis, experimental testing, analysis, and report writing.
• Previous experience working with third-party standards and regulatory requirements as required
• Understanding accuracy, repeatability and reliability of lab test results
• Proficiency in PC and basic software packages
• Knowledgeable in dental products is a plus
• Basic understanding of FDA QSR and ISO 13485 a plus
• Experience with participation in FDA or ISO 13485 quality system audits a plus

Who We Are

As one of the world’s leading dental companies, Kulzer has been a reliable partner for all dental professionals for over more than 80 years. Whether aesthetic or digital dentistry, tooth preservation, prosthetics, or periodontology – Kulzer stands for trusted and innovative dental products. With optimal solutions and services, Kulzer aims to support its customers in restoring their patients’ oral health in a safe, simple and efficient way. For this purpose, 1500 employees work in 26 locations in the field of research, manufacturing, and marketing.

Kulzer, headquartered in Hanau, Germany, with their North American offices located in South Bend, Indiana, is part of the Mitsui Chemicals Group. The Japanese Mitsui Chemicals Inc. (MCI) based in Tokyo owns 131 affiliates with more than 13,400 employees in 27 countries. Its innovative and functional chemical products are as much in demand in the automotive, electronics and packaging industries as in environmental protection and healthcare.

Both a medium-sized company and part of a major international corporation, Kulzer combines the best of both worlds, with reliable jobs, diverse tasks, and exciting creative freedom.

If your goal is to work for a company that provides a great work-life balance, exceptional benefits package, and great pay… submit your resume and salary requirements today to: hr-department-kna@kulzer-dental.com.

We are an Equal Opportunity Employer.

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.