Quality Systems Specialist II

Imricor; Burnsville (MN); On-site; USD 75,000 - 110,000; Full time

Job summary

Imricor in Burnsville, MN seeks a Quality Systems Specialist II to support a compliant quality management system, focusing on CAPA, nonconformance, audits, document control, change control, training, and quality metric analysis.

You will lead CAPA projects, investigate quality issues, analyze data, train staff, and collaborate with engineering and manufacturing to ensure the product lifecycle meets regulatory requirements such as 21 CFR Part 820, ISO 13485, and EU MDR.

Qualifications

• Bachelor's degree in a related technical field.
• 3-5 years of experience in quality assurance or other quality systems in the medical device industry.
• Knowledge of 21 CFR Part 820, ISO 13485, EU MDR and global regulatory requirements.
• Advanced data analysis and report writing skills.

Responsibilities

• Develop and maintain quality system procedures for compliance.
• Participate in internal/external quality audits.
• Lead CAPA projects ensuring compliance and timely records.
• Investigate quality issues and perform root cause analyses.
• Lead CAPA update meetings and communications.
• Monitor quality metrics and drive corrective actions.
• Provide backup for engineering change orders and change requests.
• Develop and maintain electronic QMS processes.
• Provide cross-functional training on quality requirements.
• Collaborate with cross-functional teams to meet product lifecycle quality.
• Communicate updates to stakeholders and ensure best practices.
• Perform other duties as assigned.

Skills

CAPA

Nonconformance

Quality systems

Data analysis

Education

Bachelor's degree in a related technical field

Tools

Statistical software

Job description

Description

Supervisor’s Title: Quality Director

Exempt or Non-Exempt: Exempt

Location: Must be able to work at our Burnsville location.

Compensation: The expected salary/wage for this Minnesota-based position is between $75,000-110,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function

The Quality Systems Specialist II position is responsible for the support of a compliant and effective quality management system. Primary quality system functions include Corrective Action and Preventive Action (CAPA), Nonconformance Management, Internal and External Audit, Document and Records Management, Change Control, Training, and Quality Metric Analysis and Review.

Responsibilities

• Develops and maintains quality system procedures to ensure compliance with regulations and industry standards.
• Participates in internal and external quality audits to ensure compliance with regulations and standards.
• Participates in, or leads, the completion of CAPA projects, assuring compliance, quality, and timeliness of records.
• Investigate and resolve quality issues, including conducting root cause analysis and implementing corrective and preventive actions.
• Leads meetings and communications for CAPA updates, information, and concerns.
• Monitors and analyzes quality metrics to identify areas for improvement and initiate corrective actions.
• Provides backup support for engineering change orders and other document change requests.
• Develops and maintains electronic quality management system processes. Provides cross-functional training and support as needed.
• Collaborates with cross-functional teams to ensure quality standards are met throughout the product lifecycle.
• Communicates quality system updates and changes to relevant stakeholders.
• Provides guidance and training to the organization on quality system requirements and best practices.
• Performs other duties as assigned.

Requirements

Qualifications

• Bachelor’s degree in a related technical field.
• 3-5 years of experience in quality assurance or other quality systems roles in the medical device industry.
• Previous CAPA and nonconformance experience and demonstrated use of quality tools and methodologies.
• Detailed knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and other global regulatory requirements.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Strong verbal and written communication skills.
• Excellent attention to detail. Multitasks prioritize and meet deadlines promptly.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• 85% of time requires viewing and working at computer screen.

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.