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Quality Systems Analyst- St. Paul, MN - St Paul, United States - MGC Diagnostics
Description
Are you looking for an opportunity to grow where your experience matters? Do you strive for a career with meaning and purpose? If you thrive in a fast-paced environment and want to work with a great team, we might be a fit
MGC Diagnostics ) is a leader in providing innovative technology for cardio-respiratory diagnostics. We recognize that our success depends upon the capabilities of our employees to assist MGC Diagnostics in achieving its business goals. MGC Diagnostics is proud of its collaborative environment where it values contributions of each of its team members. We offer competitive benefits and profit sharing.
Position Title: Quality Systems Analyst
Department: Quality Assurance/ Regulatory Affairs
Location: St. Paul, MN (on-site)
PRIMARY PURPOSE
The Quality Systems Analyst/Auditor is responsible for ensuring that the Quality Management System (QMS) for our medical devices meets the required standards of regulatory bodies, both domestic and international. This role encompasses internal audit activities, external standards management, CAPA ownership and support, label management, and gap assessments related to global medical device regulations.
ORGANIZATIONAL RELATIONSHIPS
Reports to: Manager, Quality Systems
KEY RESPONSIBILITIES AND ESSENTIAL FUNCTIONS
Internal Audits:
Plan, conduct, and report on internal quality system audits.
Coordinate corrective actions and verify their effective implementation in response to audit findings.
Maintain and manage the internal audit schedule.
External Standards Management:
Track, analyze, and communicate changes to external standards that impact the medical device QMS.
Collaborate with cross-functional teams to ensure alignment with evolving standards.
CAPA Management:
Own and manage the Corrective and Preventive Action (CAPA) process.
Support other CAPA owners in the identification of root causes, implementation of corrective actions, and verification of effectiveness.
Run periodic reports and analytics on open CAPAs to identify trends and areas of improvement.
Label Management Support:
Serve as a backup for GS1 and GUDID label management processes.
Ensure labels are in compliance with relevant regulatory standards.
Regulatory Gap Assessments:
Continuously assess the QMS against global medical device regulations.
Identify, report, and mitigate any gaps or non-conformities in the QMS related to global regulations.
Continuous Improvement:
Proactively identify opportunities for process and quality improvements.
Collaborate with cross-functional teams to implement enhancements to the QMS.
QMS Training Management:
Annual QMS training
Onboard/new employee QMS training
Electronic Signature for new employees
File ECO's trainings as applicable
Support Document Control
Engineering Change Orders
Product Analysis/validations
Deviations
Filing other QMS documentation
Accept other responsibilities as assigned.
Complete training as identified by standard operating procedures and procedural work instructions.
Regular attendance is an essential job function.
Follow all Company policies and procedures relating to confidential propriety information (CPI) including but not limited to what is outlined in the Confidentiality and Non-Solicitation Agreement.
CONTACTS:
INTERNAL: All Departments
EXTERNAL: Suppliers, Customers, External Auditors and Assessors from Notified Body or other regulatory agencies
JOB SPECIFICATIONS:
Must Have – Minimum Requirements
Bachelor's Degree in Technical, Scientific, or Engineering discipline
5-7 years of experience in Quality Assurance, Regulatory Affairs, or other Quality Systems role, preferably in medical device or other regulated industry.
Knowledge of ISO 13485, ISO 14971, MDSAP, EU MDR, UK MDR and other global regulatory requirements.
Process-oriented problem solver and strong documentation creation/ management experience.
Nice to Have
Audit Experience (both as auditee and/or auditor)
WORKING CONDITIONS OR PHYSICAL REQUIREMENTS:
Will be required to regularly stand for extended periods of time; use hands and fingers, handle or feel objects, talk, hear, and see. Occasionally lift and/or move up to 50 pounds, stand, walk, climb, balance, stoop, kneel, crouch, or reach with hands and arms. Requires repetitive motion and manual dexterity. The environment is fast paced; time pressured and requires accuracy. Will be required to regularly multi-task between projects, move throughout the office building and effectively communicate. The normal production environment can be louder due to equipment running.
