Staff QA/RA Engineer Digital Solutions

Job Overview

Post Date
Number
WEBWW-2022-000005
Job Function
Digital Solutions
Location
USA
Country
United States

About the Position

Digital Strategy, Digital Solutions and the Digital Factory

Digital is a key factor for our solutions to effectively contribute to the advancement of patient care, and therefore, a strategic priority for Werfen.

We are creating a new Digital Solutions unit to lead our digital transformation so that we are better positioned to achieve our Purpose of advancing patient care and laboratory diagnostics.

As part of this transformation, we are creating the Digital Factory. The Digital Factory, based in Bedford, is a cross-functional team within Digital Solutions, driven by agile ways of working, creative problem-solving, empowered decision making and collaboration with subject matter experts across the organization to develop

innovative digital solutions.

Job Summary

The position is a technical leader and highest level individual contributor position.  He/she is responsible to ensure that activities throughout the product lifecycle are in compliance with procedures, standards and regulations applicable to our products. This position provides project/program level leadership, independently develops, applies and implements methods, tools and practices to achieve product quality and compliance goals and requirements in the areas of design, development, production, distribution, maintenance and service.  Provides mentoring and consultation and training to the projects staff.

This is a technically focused role requiring advanced skills in analyzing information, reviewing technical reports, promoting process improvement, compliance to standards, requirements development, risk management, product development and production controls, understanding of State of the Art in technology and compliance.  This position is expected to lead by example and influence the organization in alignment with the company values to achieve objectives.

Key Accountabilities

  • Provides leadership and oversight of relevant sections of the Quality System
  • Gets proactively updated on the standards and Regulations
  • Identifies compliance gaps and takes appropriate corrective actions as needed
  • Participates in the generation and review of quality documents throughout the product lifecycle
  • Advises, directs and trains teams and functional groups regarding compliance to procedures, standards and regulations, including cyber security and privacy requirements
  • Participates on suad(s) supporting new product development or design changes
  • Defends relevant quality topics in audits and corrective actions to improve and maintain compliance of the QMS
  • Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies.
  • Provides input and review on acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and complaint analysis.
  • Assures that software supporting tools are validated and in compliance with quality procedures.
  • Ensures product quality meets requirements and documentation is complete prior to approval
  • Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
  • Leads cross-functional projects on technical and quality issues
  • Supports internal and external audits
  • Support and facilitate the Regulatory Affairs activities to ensure that products comply and meet medical device regulatory requirements, through all the product life-cycle.
  • Co-ordinate Notified Body interactions.
  • Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.
  • Facilitate/manage the regulatory submissions for market authorization for medical device products.
  • Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, and Labelling.
  • Oversee post-market surveillance activities related to medical device products
  • Works withR&D, Service, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA)
  • May manage and supervise the work of others
     

Networking/Key relationships

This position will work closely with the QA/RA function as well as with all groups within the Digital Solutions Unit, as well as Marketing, Service, Medical Affairs, R&D and other functions across the organization to effectively drive solutions forward.   Interactions will include:

  • Working closely with other functions to generate compliant documents by interpreting and explaining quality procedures, applicable standards, regulations and best practices.
  • Effectively communicating quality requirements to a broad population of constituents.
  • Negotiating and influencing others in establishing direction toward improved quality and enhanced compliance.

Minimum Knowledge & Experience required for the position:

  • Bachelor's degree plus a minimum of 17 years related experience of Master's Degree plus a minimum of 15 years related experience of waiver based on experience.
  • Additional experience working in or knowledge of:
    • Software Platforms and Applications
    • Project design, validation, quality plans and risk management (including human factors engineering)
    • Managing submissions, complaint systems and/or authorities reporting activities
  • Solid knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971, ISO 62304, etc.)
  • Language: English, Spanish (desirable)

Skills & Capabilities:

The ideal candidate for this position will exhibit the following skills and capabilities:

  • Deep knowledge of domestic and international quality/regulatory standards related to Digital Medical Device products
  • Demonstrates nuanced judgment commensurate with experience regarding application of regulatory requirements to data review, reports, design changes, risk management, etc. to ensure compliance and achieving business objectives. Demonstrated understanding of risk-based approach to processes and decisions.

Competencies:

  • Attention to Detail: Ability to pay close attention to detail is required
  • Accuracy: Work is accurate and complete
  • Performance Standards: Demonstrated ability to meet department goals
  • Communication: Excellent written, verbal and presentation skills
  • Discretion: Acts with integrity in all situations and can maintain appropriate confidentiality
  • Multi-Tasking: Ability to manage multiple priorities, and support changing business needs
  • Collaboration: Ability to work within a multi-function team to bring best solutions to the team or customer
  • Independence: self-motivated-works under minimal supervision
  • Professionalism: Must demonstrate professionalism during all interactions within the company, customers and third parties
  • Takes Initiative: Serves as a role model for “Quality First” by continuously improving on what matters most to customers
  • Problem Solving: Promptly and effectively handles issues and problems
  • Decision making: Makes decisions based on data and risk determination

Additional Skills and Knowledge:

  • Broad and thorough knowledge of engineering and science theory and principles, including R&D, quality control, manufacturing and design engineering
  • Understanding of the application of technical principles and engineering problem solving to resolve complex issues.
  • Membership on external standards organizations of industry groups with influence of our products – desirable

Travel requirements:

Up to 15% of the time.