Quality Engineer II

VitalPath; Fort Snelling Unorganized Territory (MN); On-site; USD 69,000 - 87,000; Full time

Benefits offered by this job

Health and Dental Insurance

Vision Insurance

HSA with Company Contribution

Paid Time Off

401K with Company Match

Parental Leave

Job summary

VitalPath in Maplewood, MN is seeking a Quality Engineer II to provide cross-functional quality support across development and manufacturing, ensuring customer requirements are understood and properly implemented. The role focuses on non-conformance processing, CAPA, supplier control, and audits, with opportunities to advance quality systems, document control, and training for personnel.

Onsite work is required at our Maplewood facility, with a collaborative team environment and a path to grow

Qualifications

• Bachelor’s degree in engineering or related field.
• At least 3 years in a quality role in a medical device manufacturing environment.
• Experience with ISO 13485:2016 audits and QMS.

Responsibilities

• Support manufacturing, inspection, qualification, and validation of products.
• Develop and implement quality improvement with working knowledge of Quality standards and systems.
• Assures compliance of the Quality Management System (QMS), ISO 13485:2016, and customer/regulatory requirements.
• Works with customers and suppliers to resolve quality related issues.
• Support and participate in 3rd Party and customer audits, as needed.
• Work crossfunctionally on failure investigations, rootcause analysis, and corrective action implementation.
• Develop, approve, review, and updatecontrolled documents such as Procedures, Manufacturing Procedures, Work Instructions, Forms, etc.
• Train personnel, as needed, on new or updated QMS documents.
• Review and approve customer and internal drawings and specifications.
• Ensure that records are established, accurate and maintained per QMS requirements.
• Develop and implement systems for Quality and Inspection support.
• Support implementation of overall company systems that relates to Quality.
• Other duties as assigned.

Education

Bachelor’s Degree in Engineering or related discipline

Job description

Join VitalPath in Maplewood as a Quality Engineer II!

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 Engineer II is primarily responsible for providing technical support to ensure Customer requirements are understood and properly implemented. The Quality Engineer II will work cross-functionally contributing to Development and Manufacturing, Engineering, Qualification, and Validation activities. Supports Operations, Sales, and Quality by providing effective Non-conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities.

Work Location/Schedule

• This position requires the employee to be onsite at our VitalPath Maplewood, MN location
• VitalPath does not offer relocation assistance for this position.

Responsibilities

• Support manufacturing, inspection, qualification, and validation of products.
• Develop and implement quality improvement with working knowledge of Quality standards and systems.
• Assures compliance of the Quality Management System (QMS), ISO 13485:2016, and customer/regulatory requirements.
• Works with customers and suppliers to resolve quality related issues.
• Support and participate in 3rd Party and customer audits, as needed.
• Work crossfunctionally on failure investigations, rootcause analysis, and corrective action implementation.
• Develop, approve, review, and updatecontrolled documents such as Procedures, Manufacturing Procedures, Work Instructions, Forms, etc.
• Train personnel, as needed, on new or updated QMS documents.
• Review and approve customer and internal drawings and specifications.
• Ensure that records are established, accurate and maintained per QMS requirements.
• Develop and implement systems for Quality and Inspection support.
• Support implementation of overall company systems that relates to Quality.
• Other duties as assigned.

Required Qualifications

• Bachelor’s Degree in Engineering or related discipline
• 3 years of experience in a quality role in a medical device manufacturing environment
• 3 years of experience in support of QMS audits
• Experience with ISO 13485:2016 or related ISO standard
• Able to sit/stand for extended periods of time

Preferred Qualifications

• Demonstrated experience in software validation
• Experience in manufacturing of catheters
• 2 years of experience working with automated inspection systems

Compensation Package

• The salary range for this position is $69,300 $87,000 . 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, 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.