Job Description

Our start-up medical device client is adding a Design Assurance Manager to the team. The DA Manager works cross-functionally and is responsible for providing Design Assurance representation on teams, facilitating design verification and validation for transfer to manufacturing, and implementing process/product improvements. The manager also supports quality management system process development and execution for applicable processes. The role has shared responsibility for product safety and quality in all stages of product and process development, and ensuring compliance with design specifications, quality management system procedures associated with design assurance, and all applicable regulatory requirements.

Your role with the company:

Responsible for implementing measurement systems analysis and standardizing documented quality tools such as root cause analysis, flowcharts, cause and effect diagrams, control charts, APQP / PPAP, FMEA, DOE, and other applicable statistical methods.

· Responsible for developing, improving, and managing design assurance processes such as failure analysis, design verification and validation, risk management, design and process-related CAPAs, and complaint handling processes.

· Manage the risk management process by ISO 14971, including risk management plans, hazard analysis, user risk analysis, FMEAs, and risk management reports, throughout all product development phases.

· Responsible for tracking, analyzing, and reporting on quality and business measurements such as design verification failures, complaints, and CAPAs. Supports the analysis and evaluation of design verification capabilities and the design and development of new products from the design assurance perspective.

· Partner with other functional areas, primarily R&D, in areas such as preparing test plans, data analysis, specifications, risk analysis, proposed change assessments, and change implementation. Interpret and contribute to electro-mechanical systems, software design, and testing. Ensure clarity and consistency in acceptance criteria and ensure the verification processes used are capable and statistically relevant.

Manage People

· Manage DA staff and technical improvement projects

· Technically excellent with deep and broad experience in DA

· Hands-on, dives in, takes ownership

· Data visibility and integration into our DA processes

· Use of Quality Tools - routine use of documented root cause analysis and other Quality Tools

Manage Products

· Responsible for all Design Assurance activities for Francis Medical capital, reusable, disposable, and software products

· Experience with biocompatibility, human factors, electrical safety, hardware, and sterilization industry standards and testing.

Manage Processes

· Data Analysis: standardized use of statistical tools across QMS

· Root Cause Analysis: standardized documented use of Quality Tools

· DA process

· Data visibility and integration into our processes, broad implementation of JMP

· Efficient and effective verification processes that measure and report all aspects of the verification process

· Planning – test method metrics (who, how long, sequencing efficiency)

· Execution – coordination and real-time visibility to status

·**Failure Analysis** for complaints, NCM, CAPA - key process for DA

· Reporting – JMP ready, real-time reporting, stability / capability

· Risk Management process

· IEC 60601 compliant risk management file

· JAMA Direct implementation

· GAS risk management module implementation

· Usability of risk management system by engineers and regulatory, visibility for QMS review

· Corrective and Preventive Action (CAPA) – design and process related CAPAs

· Complaint investigation, **failure analysis**, and reporting

Desired Profile:

BS Engineering (EE, ME, BME) ideal

Certifications (ASQ CQE, SSBB, MQ/OE, CSCP, CQA)

· Experience managing people and in-depth knowledge of Quality Management System processes

• Minimum 10 years of experience working in the medical device industry.

· Breadth across development timelines, across functions, and company sizes

· Depth into each area of QA, hands on involvement, experience, and learning

• Proficient in statistics and statistical software, preferably JMP

· Curiosity, learning, strong work ethic, getting involved, continuously improving

· Outstanding integrity, character, and trustworthiness; demonstrated evidence of leadership, creativity, adaptability, determination, perseverance and excellent communication

· Ability to respond to inquiries or complaints from customers, regulatory agencies, or members of the business community in all areas of Quality Assurance.

Experience in statistics, statistical software, and Quality Tools a plus

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