Quality System Specialist

VitalPath; Minnesota; In loco; USD 70.000 - 82.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

401K with company match

Paid time off

Descrizione del lavoro

VitalPath seeks a Quality Systems Specialist to support the execution and maintenance of a harmonized quality management system across multiple manufacturing sites in a regulated medical device environment.

You will coordinate document control, training compliance, CAPA coordination, change control administration, and audit readiness activities, partnering with cross-functional teams to ensure compliance with FDA, ISO 13485 and internal requirements.

Competenze

• Bachelor’s degree or equivalent experience.
• Minimum 2 years of experience in a regulated manufacturing environment, preferably within the medical device area.
• Working knowledge of Quality Management System (QM) principles and regulatory requirements.
• Familiarity with electronic quality systems and document management systems.

Mansioni

• Support the administration and maintenance of a harmonized Quality Management System (QMS) across multiple manufacturing sites.
• Coordinate quality system processes including document control, training management, change control, deviations, and CAPA activities.
• Maintain quality records to ensure completeness, accuracy, and compliance with applicable regulatory requirements and internal procedures.
• Assist with administration of the QCBD training management system, including training assignments, training record maintenance, and compliance monitoring.
• Assist departments in resolving routine quality system and training compliance issues.
• Support the review, routing, and processing of controlled documents and quality system records.
• Participate in investigations of nonconformances, deviations, and audit observations by gathering data and supporting root cause analysis activities.
• Assist with preparation for internal audits, customer audits, and regulatory inspections.
• Generate and maintain quality system metrics and reports to support management review activities.
• Collaborate with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and Operations personnel to ensure consistent application of quality system requirements.
• Identify opportunities for process improvements and standardization within quality system processes.
• Support implementation of new or revised corporate quality system procedures across multiple sites.
• Maintain a working knowledge of applicable regulatory requirements and internal procedures necessary to perform assigned responsibilities.
• Other duties as assigned.

Conoscenze

QM principles

Regulatory compliance

Documentation skills

Communication skills

Formazione

Bachelor’s degree or equivalent experience

Strumenti

QMS software

Document management systems

Descrizione del lavoro

Join VitalPath in Maplewood as a Quality Systems Specialist!

About VitalPath

VitalPath is a trusted contract manufacturing partner that delivers high-quality complex catheter solutions around the world that save lives and restore patient health and vital function. We strive to treat every product we design and manufacture to the highest level of quality and awareness that these products are going to be used inside of a patient, possibly even our own family members.

Our employees impassioned hard work and dedication are at the core of our success. Every function within our organization plays a crucial role in our mission and is deeply valued for its contribution to achieving our shared goals of quality, innovation, continuous improvement, and operational excellence.

As a fast-growing organization, we bring harmony and standardization across VitalPath with a strong vision in mind - We are one VitalPath. We embrace our diversity, celebrate each others success, support one another through change, and continue to grow as a high-performing organization. We aim to shape our corporate culture to enhance team member engagement, skills, and productivity so that VitalPath is an employer of choice. If you’re ready to contribute to groundbreaking medical advancements in a collaborative, fast paced environment, we invite you to apply and be part of our growth!

About The Position

The Quality Systems Specialist supports the execution and maintenance of a harmonized quality Management System (QMS) across multiple manufacturing sites within a regulated medical device environment. This role supports core quality systems process including document control, training compliance, CAPA coordination, change control administration and audit readiness activities. In partnership with cross-functional teams to ensure the quality system activities are executed consistently and in compliance with FDA, ISO 13485, customer and internal quality requirements.

Work Location/Schedule

• This position requires the employee to be onsite at our VitalPath MN location.
• Shift/Schedule: Monday Thursday 9 hour days, Friday 4 hour day
• VitalPath does not offer relocation assistance for this position.

Responsibilities

• Support the administration and maintenance of a harmonized Quality Management System (QMS) across multiple manufacturing sites.
• Coordinate quality system processes including document control, training management, change control, deviations, and CAPA activities.
• Maintain quality records to ensure completeness, accuracy, and compliance with applicable regulatory requirements and internal procedures.
• Support administration of the QCBD training management system, including training assignments, training record maintenance, and compliance monitoring.
• Assist departments in resolving routine quality system and training compliance issues.
• Support the review, routing, and processing of controlled documents and quality system records.
• Participate in investigations of nonconformances, deviations, and audit observations by gathering data and supporting root cause analysis activities.
• Assist with preparation for internal audits, customer audits, and regulatory inspections.
• Generate and maintain quality system metrics and reports to support management review activities.
• Collaborate with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and Operations personnel to ensure consistent application of quality system requirements.
• Identify opportunities for process improvements and standardization within quality system processes.
• Support implementation of new or revised corporate quality system procedures across multiple sites.
• Maintain a working knowledge of applicable regulatory requirements and internal procedures necessary to perform assigned responsibilities.
• Other duties as assigned.

Required Qualifications

• Bachelor’s degree or equivalent experience
• Minimum 2 years of experience in a regulated manufacturing environment, preferably within the medical device area
• Working knowledge of Quality Management System (QM) principles and regulatory requirements
• Familiarity with electronic quality systems and document management systems
• Strong organizational and documentation skills
• Effective written and verbal communication skills
• Strong attention to detail and commitment to compliance

Compensation Package

• The salary range for this position is $70,000 $82,000 . The posted salary range complies with federal and local regulations and may vary based on factors such as market conditions, level of experience and training, education, certifications, as well as internal and external equity.
• This position is eligible to earn an annual performance bonus based on meeting VitalPath’s bonus performance plan.

Benefits

• Comprehensive, Low Cost Health and Dental Insurance Plans Available
• Vision Insurance
• Health Savings Account with company contribution
• Short and Long Term Disability
• Supplemental insurances (short term disability, AD&D, life insurance, MN paid family & medical leave, and more)
• Parental Leave
• Paid Time Off
• Minnesota Earned Sick & Safe Time
• Paid Holidays
• 401K with company match
• Opportunities for career growth and advancement

VitalPath is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, work related mental or physical disability, veteran status, sexual orientation, gender identity, or genetic information. VitalPath participates in E-Verify.