Quality Engineer II

Join VitalPath in New Hope as a Quality Engineer II!

About VitalPath

VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We’re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it’s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people’s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team!

About The Position

This person 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 Engineering, Operations, Sales, and Quality by providing effective Non-conformance processing, Supplier control and Outsourced services integrity, Complaint handling, and related CAPA activities.

Responsibilities

• Support engineering, 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 Systems (QMS), ISO 13485:2016, and customer/regulatory requirements
• Support Development activities for the transition of Manufacturing Processes and related controlled documentation from prototype control to pre-production control to commercial production control
• Works with customers and suppliers to resolve quality related issues
• Support and participate in 3rd party and customer audits, as needed
• Work cross-functionally on failure investigations, root-cause analysis, and corrective action implementation
• Develop, approve, review, and update controlled 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 QMD requirements
• Develop and implement systems for Quality and Inspection support
• Support implementation of overall company systems that related to Quality
• Other duties as assigned
  
  

Requirements

• Bachelor’s Degree in engineering or related discipline
• 3 years of Quality Engineering experience in catheter medical device manufacturing
• 3 years of experience in support of QMS audits
• Experience working in quality systems defined in 21 CFR 820 and ISO 13485
• Demonstrated ability to implement, execute, and maintain quality system policies and procedures
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Diverse knowledge of inspection and control methods, techniques, and documentation
• Ability to interpret and understand drawing specifications, tolerances, procedures for inspection, and the application of sampling plans
• Able to sit/stand at a desk for extended periods of time
  
  

Preferred Skills & Experience

• 2 years’ experience working with automated inspection systems
• Demonstrated experience in software validation
• Experience in product development and process design development team environment
  
  

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)
• Paid Time Off
• Sick Time Off
• Paid Holidays
• 401K with company match
• Competitive compensation
• 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.

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