Associate Quality Assurance Director, Medical Device Combination Products Software (Remote)

Job Description
We are seeking a Growth and Improvement minded Associate Quality Assurance Director, Medical Device Combination Products Software that can help drive our Strategic Operating Priorities.

• Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
• Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
• Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
• Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
• Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us

Summary, Focus and Purpose
The Associate Quality Assurance Director, Medical Device Combination Products Software will be responsible for Software Quality and Validation activities including the review of Use and Functional Device Requirements, Design Specifications, review and approval of test protocols and reports, Validation Plans and Reports, Trace Matrices, and process validations related to Software as a Medical Device. Ability to create and meet deliverables per Project Schedule and support teams advising on the correct cGMP approach to allow software analysis and criteria assessment prior to product acceptance testing, a mandatory prerequisite for new product commercialization.
This position will be an individual contributor role on the Medical Device and Combination Product Quality Team and will report to the Director MDCP Quality Assurance, this role is responsible for independent compliance support of Medical Devices including the device constituent part of Combination Products. You will interact with cross functional teams working with all levels of employees, including developing, documenting, and maintenance of technical business and systems to ensure compliance with FDA Medical Device Regulation (21CFR 820), Combination Products Regulation (21CFR Part 4), Device Risk Management (ISO 14971), IEC 62304: Medical Device Software Lifecycle and other worldwide regulations and company requirements.
This position provides Software Device Quality Assurance support to ensure successful quality oversight of prospective Medical Devices and the device constituent part of Combination Products to meet Health Authority (HA) regulations, international standards, and company procedures.
Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Supporting the Device Software Development Lifecycle process and procedures to ensure that the software design requirements are planned, documented, tested, released, and maintained
• Ensure the Design Verification and Validation of Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) follow HA regulations, international standards, and company procedures
• Support the Device Software Risk Management process and procedures, including safety classifications, to ensure software risks are properly assessed and controlled throughout the life of the product
• Ensure the Device Software Maintenance process and procedures are established and maintained to ensure software feedback, evaluation, and resolution after release incorporating risk and change management
• Collaborate with QMS team to provide test documentation for regulatory submissions. Review requirements, specifications and design documents
• Develop, review & approve validation plans, protocols and reports, traceability matrices and other documentation as required and provide timely feedback by driving efficiencies in processes
• Develop, execute, review & approve user acceptance protocols, Functional & System test protocols:
  - Familiarity with various software tools (e.g., configuration management, issue/defect tracking, requirements analysis, etc.)
  - Support software tools validation efforts and apply knowledge of SDLC, from Requirements through System Retirement, including Risk Management and Change Control
• Actively represent MDCP Quality Operations function on commercial and product/core development teams supporting quality issues related to Medical Devices or the device constituent of a combination product
• Contribute to developing/revising procedures for MDCP Quality and/or supported areas. Remain informed of industry trends as described in worldwide regulations and industry standards
• Provide guidance to our Manufacturing Division and our Research and Development Div device functions and other personnel to ensure end-to-end Design Control principles are implemented effectively
• Participate in software design reviews, CAPA reviews, and ad-hoc technical reviews of Medical Device Combination Products
• Participate in all stages of Medical Device Combination product software development including, but not limited to purchasing controls and supplier quality management systems
• Work with external contract manufacturing organizations, suppliers, alliance partners to develop new SaMD or SiMD products. Review and approve verification/validation test protocols and reports to ensure that the testing is sufficient to meet quality and regulatory requirements
• Provide input to design and manufacturing documentation including material/component specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be manufactured, and tested
• Facilitate translation of customer needs into critical to quality and design input/output requirements, including, but not limited to chemical, physical, or performance specifications
• Develop, modify, and execute software test plans, automated scripts, and programs for testing. Analyze and write test standards and procedures. Maintain documentation of test results to assist in debugging and modification of software
• Analyze test results to ensure existing functionality and recommend corrective action. Consult with development engineers in resolution of problems. Provide feedback in preparing technical programming languages, systems, and computation software. Help the team automate and implement end-to-end test framework for API and UI testing
• Ensure Computer Integration into Device Functions of Scientific computation and data acquisition, migration and processing transfer
• Provide feedback in preparation of technical appraisals of programming languages, systems, and computation software
• Help the automation team to implement, enhance and maintain an end-to-end test automation framework for API and UI testing
• Ensure quality computer integration into the overall functions of scientific computation, data acquisition, and processing
• Develop, modify, and execute software test plans, automated scripts, and programs for testing
• Analyze and write test standards and procedures. Maintain documentation of test results to assist in debugging and modification of software
• Analyze test results to ensure existing functionality and recommend corrective action
• Consult with development engineers in resolution of problems
• Provide feedback in preparation of technical appraisals of programming languages, systems, and computation software
• Help the automation team to implement, enhance and maintain an end-to-end test automation framework for API and UI testing
• Ensure quality computer integration into the overall functions of scientific computation, data acquisition, and processing

Education

• Bachelor degree of Science (BS) in Engineering/Scientific/Computer Systems/IT/Software with seven years of experience in Software Medical Device Lifecycle Processes or
• Master degree of Science (MS) in Engineering/Scientific/Computer Systems/IT/Software with five years of experience in Software Medical Device Lifecycle Processes

Required

• Experience with Design Controls / CAPA / Purchasing Controls as it related to 21 CFR Part 4
• Knowledge of applicable Medical Device regulations (21 CFR Part 820, EU Medical Device Regulation, ISO 13485:2016)
• Risk Management experience (ISO 14971:2019)
• Knowledge of IEC 62304: Medical Device Software Life-Cycle Processes
• Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with the Medical Devices
• Work independently within a cross functional framework and will involve detailed technical writing and review. A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems
• Work in a matrix organization and effective written and verbal communicator

Preferred

• Six Sigma Green Belt or ASQ (American Society for Quality) certifications (i.e., CQE, CSQE)
• Strong understanding of current Good Manufacturing Practices (cGMP), current Good Documentation Practices (cGDP); and project management principles
• Lean Six Sigma Principles and tools such as: Design of Experiments (DOEs), Failure Mode Effect Analysis (FMEA's), Root cause analysis and/or Problem-solving methods
• Experience in the use of root cause analysis tools with applied statistical techniques
• Work independently to create, maintain, and execute test plans. Provide technical guidance to the test engineers on test strategy, test plans and day to day activities. Provide test leadership for the project and feature teams
• Create traceability between test plans and formal requirement documents. Participate in Scrum meetings if applicable, be involved in requirements gathering, the creation of use requirements, test plan, test cases, and defect categories related to risk
• Identify software defects as early as possible in the software development process and provide problem resolution to management
• Work with the development team to improve unit test coverage, integration tests, frameworks, and productivity tools
• Work with cross-functional teams and a variety of disciplines such as scientists, regulatory, and quality to gain an understanding of the product which will aid the creation of the test strategy and test plans
• Participate in the evaluation of tools, test development, automation environment used for software verification
• Help automation team to implement, enhance and maintain an end-to-end test automation framework for end-to-end testing
• Mentor other team members in quality testing best practices and skills development

Demographics

• US Based | NJ/PA or other US location
• Travel | 25% of the time

NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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