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, as they relate to manufactured product.
• Identification and interpretation of recognized standards for medical manufacturing (. 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 opportunity for employment, regardless of race, color, creed / religion, sex, sexual orientation, marital status, age, mental or physical disability.

We thank all applicants in advance; however only individuals selected for an interview will be contacted. All applications will be kept confidential.