Senior Engineer, Operations Quality

 

Overview

 

The Sr Operations Quality Assurance Engineer is responsible for compliance to procedures and regulations for Manufacturing Controls of Implant and Externals Products and works within a multidisciplinary product development team to ensure the design intent of products is realized effectively and efficiently, including compliance with 21CFR820, ISO13485, ISO 14971, MDSAP and MDR. 

 

 

What you’ll do:

 

• Manages all Manufacturing Quality Assurance aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives
• Partnering with Receiving inspection, Quality control and supplier quality to ensure a streamlined manufacturing process is maintained
• Support 3rd party audits regarding manufacturing processes and policies
• Experienced in class III sterile implantable medical devices
• Provides status reporting regarding manufacturing processes deliverable, dependencies, risks and issues, communicating across teams and to direct management
• Provides expertise to the manufacturing and design team on the implementation of international standards (ISO 14971, ISO 13485, particular standards, etc.) as they relate to manufactured product.
• Identification and interpretation of recognized standards for medical manufacturing (e.g. ISO 13485, 21 CFR 820, MDSAP, EUMDR etc)
• Requirements discovery as solicited from Engineering, Marketing, Clinical, and Regulatory stakeholders
• Ensure product meets and exceeds product specifications, regulatory requirements, and international standards
• Responsible for various testing planning, execution and reporting, including design transfer, IQ, OQ, PQ. Verification and Validation of manufacturing processes and tooling etc.
• Recommends process improvements to management and executes to ensure consistent implementation of internal requirements and external regulations and standards.
• Participates in the investigations and dispositions of product, non-conformances and changes, CAPA, NCMR, MRB
• As needed, prepares documentation for and support regulatory submissions (USA, EU, International)
• May create and/or delivery training on compliance of medical devices per international standards
• May mentor, train or otherwise provide guidance to newer or less experienced team members, leveraging product skills and experience
• General quality support as required and other duties as assigned.
• QA representative on cross functional teams, GEMBA walks, Manufacturing Kaizen Events
• Other duties as assigned.

 

 

Travelling Requirement: 10%

 

 

 

 

What you bring to the team:

 

 

 

Education

• Bachelor’s Degree (and/or # of years of equivalent work experience)

Nice to Have

• Bachelor’s Degree in Engineering or advanced degree

 

 

Work Experience

• 5 years of previous Quality Engineering in Medical Device Manufacturing

Nice to Have

• 5 years of previous Quality Engineering in Medical Device Manufacturing for Class III Active Implantable Devices

 

 

Personal Competencies

• Must be able to work with all levels of management and ability to manage a team of engineers.

 

 

Social Competencies

• Ability to work under pressure and meet project timelines across departments

 

 

Leadership Competencies

• Ability to drive Continuous Improvement through collaboration and consensus building.

 

 

Professional Competencies

• Must be able to work with all levels of management and peers. 
• Ability to maintain professionalism among peers and communicate effectively will all levels of the organization

 

 

Language(s)/ Level

• English/ Proficient

Nice to Have

• Spanish/ Fluent

 

 

IT Skills

• Microsoft Office/Engineering Software

Nice to Have

• Agile PLM; SAP

 

 

 

 

 

 

Our offer:

 

• Exciting and challenging work environment
• Comprehensive benefits package
• Training and development opportunities – we believe every employee deserves a development plan. Come, learn, and grow with us!

Don't meet all the criteria?  If you’re willing to go all in and learn we'd love to hear from you! 

We love to work with great people and strongly believe that a diverse team makes us better.  We guarantee every person equal treatment in regard to employment and opportun