Senior Engineer, Operations Quality

Who we are

In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, through our core business brands – Advanced Bionics, Audiological Care, Phonak, Sennheiser (under license) and Unitron – we develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

Senior Engineer, Operations Quality (Onsite)

The Senior Engineer, Operations Quality 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.

Responsibilities:

• 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, supplier quality, and Manufacturing/ Operations to ensure a streamlined manufacturing process is maintained
• Support 3rd party audits regarding manufacturing processes and policies
• 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 or 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 / Supports investigations and dispositions of product, non- conformances and changes, CAPA, NCMR, MRB
• Supports/ Reviews root cause analysis/assessments of products, systems, and processes.
• As needed, prepares documentation for and support regulatory submissions (USA, EU, International)
• Creates and/or delivers training on compliance of medical devices per international standards
• Mentor, train or otherwise provide guidance to newer or less experienced team members, leveraging product skills and experience
• QA representative on cross functional teams, GEMBA walks, and/ or Manufacturing Kaizen Events
• Provides ge