Quality Control Specialist_Chemist I

The Quality Control Specialist serves as a technical expert in laboratory quality operations, QC testing, QC method development, and ISO 9001 compliance. This role provides hands-on analytical expertise, supports production and R&D teams, and ensures ISurTec’s products meet the highest standards of quality and regulatory compliance. The specialist plays a key role in maintaining the Quality Management System (QMS), supporting certification activities, writing documentation, and contributing to internal and external audits.

Key Responsibilities

• Perform and document QC tests and inspections on raw materials, in-process materials, and finished products.
• Develop, validate, and maintain QC test methods for coating technologies, including both chemical and physical property testing.
• Act as a subject matter expert on QC methods and instrumentation; train team members on proper test execution and documentation.
• Investigate product deviations and failures using root-cause analysis and recommend data-driven corrective actions.
• Support the build-out, maintenance, and alignment of the ISO 13485-compliant QMS; contribute to certification activities and ongoing compliance.
• Analyze QC data, perform statistical process control (SPC), and prepare technical summaries and reports.
• Conduct capability studies and participate in continuous improvement activities related to product and process quality.
• Maintain calibration, qualification, and preventive maintenance schedules for QC equipment.
• Support verification and validation (V&V) activities, including material characterization and process validation (IQ/OQ/PQ).
• Participate in internal and customer audits by providing technical documentation and process knowledge.
• Ensure safe laboratory operation and compliance with health, safety, and hygiene requirements.
• Perform additional quality-related laboratory duties as needed.

Required Qualifications

• Hands-on experience working within an ISO 9001 environment is required.
• Minimum 3-5 years of QC or laboratory experience in a regulated industry (medical device, pharmaceutical, or coatings preferred).
• Strong background in medical device coatings, polymer chemistry, or surface chemistry is highly desirable.
• Proficiency with analytical instrumentation such as UV-Vis spectrophotometers, viscometers, contact angle systems, or similar equipment.
• Experience developing and executing validation protocols (IQ/OQ/PQ) and writing technical reports.
• Strong skills in statistical analysis, SPC, and data interpretation.
• Excellent attention to detail, documentation accuracy, and organizational skills.
• Effective written and verbal communication for technical documentation and cross-functional collaboration.
• Ability to work independently, troubleshoot technical issues, and prioritize multiple tasks in a fast-paced environment.

Education

• Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, or a related technical field with strong chemistry proficiency.

Additional information:

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

Job Type: Full-time

Pay: From $51,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Education:

• Bachelor's (Preferred)

Ability to Relocate:

• Saint Paul, MN 55114: Relocate before starting work (Preferred)

Work Location: In person

Salary : $51,000