Quality Assurance Chemist

ISurTec; Saint Paul (MN); On-site; USD 55,000 - 90,000; Full time

Job summary

Join a forward-thinking company as a Quality Assurance Chemist, where your expertise in chemistry will help ensure the highest quality standards in innovative medical device coatings. This role involves developing quality control tests, participating in audits, and supporting production activities in a collaborative environment. With a focus on analytical techniques and instrumentation, you will contribute to cutting-edge advancements that enhance the performance and safety of medical devices. If you are passionate about quality assurance and eager to make a significant impact in biotechnology, this is the perfect opportunity for you.

Benefits

100% Premium Paid Medical Benefits

100% Premium Paid Dental Benefits

Voluntary Life Insurance

FSA Plan Options

Short-term & Long-term Disability

401k Plan with Company Match

Tuition Reimbursement

Qualifications

• Bachelor’s degree in Chemistry or related field with strong chemistry proficiency.
• 2-3 years of quality experience in regulated industries like medical devices.

Responsibilities

• Perform QC tests on reagents and coating solutions.
• Lead Raw Material QC development and optimize test methods.
• Conduct investigations and root cause analysis on product issues.

Skills

Analytical Techniques

Instrumentation Skills

Statistical Analysis

Communication Skills

Attention to Detail

Self-Motivation

Education

Bachelor’s degree in Chemistry

Relevant degree in Biochemistry or Chemical Engineering

Tools

Microsoft Office (Word, Excel)

Nuclear Magnetic Resonance (NMR)

Ultraviolet (UV) Testing

Job description

ISurTec Greater Minneapolis-St. Paul Area

Quality Assurance Chemist

Innovative Surface Technologies, Inc. (ISurTec) is looking for a highly motivated Quality Assurance Chemist. This position will assist day-to-day quality laboratory operations, develop quality control (QC) tests and inspection methods, and support production in any quality related activities following ISurTec’s Quality Management System (QMS). This role will also actively participate in verification and validation activities, product issue investigations, and audits.

ISurTec develops coatings to control protein and cell adhesion and control friction and wettability on surfaces, allowing devices to gain and retain their functions longer. For example, when a medical device enters the body, a cascade of biological actions occurs at the surface. Our medical device coating products control the surface properties to minimize harm to the body and to the medical device from those biological interactions. The ISurGlide hydrophilic lubricious coatings reduce tissue damage and allow coated devices to easily glide into and exit the body.

Responsibilities:

1. Perform QC tests or inspections on ISurTec reagents and coating solutions
2. Lead Raw Material QC development project by developing and optimizing test and inspection methods, and determining specifications for these raw materials
3. Develop QC test, inspection, and relevant documentation, as well as train personnel on these developed methods such as Ultraviolet (UV), viscosity, Nuclear Magnetic Resonance (NMR), and other standard analytical chemistry tests
4. Conduct investigations and root cause analysis on product issues and deviations
5. Gather data, analyze, and report on key metrics
6. Perform statistical process control (SPC) analysis
7. Coordinate and perform equipment maintenance (includes preventive maintenance, calibration, and monitoring measurements)
8. Participate in verification and validation activities for products, processes, test methods, equipment, etc. and create protocols as well as write reports
9. Participate in internal and external (customer and regulatory) audits
10. Adhere to all company safety, health, and hygiene policies, procedures, and directives
11. Miscellaneous other duties as assigned

Education and Qualification:

1. Bachelor’s degree in chemistry or other relevant degree accepted with strong chemistry proficiency such as biochemistry, chemical engineering
2. Minimum 2-3 years’ quality experience in a regulated industry such as medical devices, pharmaceuticals, or coatings
3. Experience working with good clinical, laboratory, and manufacturing practices (GxP)

Additional Knowledge Skills & Abilities:

1. Strong analytical technique and instrumentation skills
2. Well-versed in regulations such as ISO 13485, ISO 17025, EU MDR, and others
3. Experience or Knowledge on writing validation protocols/reports
4. Quality Engineer or Quality Auditor credentials preferred
5. Proficient in Microsoft Office- Word and Excel
6. Proficient in Statistical Analysis and data interpretation
7. Strong attention to detail and diligent execution of tasks
8. Excellent organizational skills with the ability to perform multiple tasks simultaneously
9. Good oral and written communication skills
10. Capacity to work independently – must be self-motivated once given direction

Additional information:

• Vaccination Requirements: COVID-19 vaccine may be required due to essential functions of this role. Requests for reasonable accommodation (for disability related, religious reasons, relocation) can be discussed post offer of employment

Benefits Include:

1. Medical benefits, 100% premium paid
2. Dental benefits, 100% premium paid
3. Voluntary Life
4. FSA Plan options
5. Life Insurance, Short-term, & Long-term disability
6. 401k plan with company match
7. Tuition Reimbursement

Innovative Surface Technologies, Inc., is an equal opportunity employer. Join ISurTec and contribute to cutting-edge advancements in medical device coatings while ensuring the highest quality standards!

Email Resume to:

Robin L Peterson, Human Resources Manager

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Research, Analyst, and Information Technology

Industries

Biotechnology