Principal Quality Engineer – Development (728813)

The Judge Group
Published
July 14, 2021
Location
Atlanta, GA
Category
Job Type

Description

Location: REMOTE
Salary: Annual Salaried Position
Description: Our client is currently seeking a Principal Quality Engineer – Development (728813) Full Time Perm Employment , Contact Brian at 732.497.4294, [Click Here to Email Your Resumé]

Principal Quality Engineer – Development Quality
Relevant Experience 
(in Yrs)
•Master’s degree and 6 years of quality experience – combination products/pharma/medical device industry
OR
•Bachelor’s degree and 8 years of quality experience - combination products/pharma/medical device industry
Technical/Functional SkillsThe Principal Quality Engineer – Development Quality is accountable for advice to, and oversight of, technical aspects in design control, and transfers.  In addition, this role will be a single Quality point of contact for device design and related issues in development of combination and non-combination products. Accountable for ensuring that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Independently manages high complexity programs with greater risk to the business including those which are novel or new, including electromechanical, and/or internally developed. Responsible to represent FPTQ (Final Product Technical Quality) Development in external engagements. Provides oversight of proper quality resource balancing on project(s) as required, ensuring FPTQ resources are proactively managed. 
•Reviews and approves Design History File (DHF) content and technical documentation and assessments throughout 
         the design & development lifecycle, including content from suppliers and partners. Participates in definition and 
         development of final product requirements, in particular for specialized products. Approves device components and 
         final 
        product or the device constituent of a combination product specification as part of development program.  
•Establishes the quality requirements for development process to transfer design. Participates in technical aspects of 
        problem-solving, complaints, and other investigations in relevant design control phases. Participates in non-design 
        control 
        investigations on an as needed basis.
•Responsible for creation, updating, and maintenance of Traceability Matrix. Develops and maintains final product 
         quality plan. Quality approval at all key design phases (i.e. verification, validation, development, and launch 
        readiness) and 
        key participant at design reviews. Quality approver of the Design History File. 
•Ensures that all Quality Requirements have been met and DHF is ready for Prior Approval Inspections (PAIs), 
        Inspection Readiness Activities, and Partner Audits. Obtains, reviews, and confirms readiness of documentation for 
        inspections. Ensure control strategies have been established, implemented, and maintained throughout the design 
         and development lifecycle. 
•Represents FPTQ at TCP or External Engagement initiatives as necessary. Acts as delegate for head of FPTQ 
        Development Quality as needed.
•Supports development of program-related quality agreements. Participates in generation of development agreements 
        with third parties.
Key Responsibilities:
•Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non- 
        combination products associated with Final Product Technologies activities. 
•Attend development program meetings as required as part of program working teams. 
•Work cross-functionally with individuals and project teams to ensure success of development project efforts. 
•Provide guidance on documentation structures created during development activities. 
•Identify proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design 
        and development process to ensure compliance with applicable regulations and Procedures. 
•Provide input to the Design and Development Plans for projects, and review and approve relevant combination 
        product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, 
        Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, 
        Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration 
        specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), 
        Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated 
        projects. 
•Actively participate and contribute to applicable Design Control Phase Design Reviews. 
•Provide Quality oversight of Design Characterization and Verification and Validation activities. 
•Ensure adherence to all relevant regulations and standards based on the type of device under development. 
•Represent FPTQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of 
        supplier qualification and development as it relates to design control activities. 
•Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal 
        written responses. Participates in audits and inspections, is well prepared by owning relevant details that are 
        supported by 
        evidence and for associated projects. 
•Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, 
        fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems. 
•Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s). 
•Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk 
        Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) 
        Protocols and Reports, as well as onboarding and auditing HFE suppliers
        Competencies
•Deep and broad understanding of quality processes including change control, design controls, risk assessment and 
        management, and root cause analysis.
•Deep combination product expertise and experience including functional knowledge of applicable guidance, 
        regulations and standards to enable future compliance as projects enter design controls
•Strong knowledge of quality engineering and device engineering
•Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
•Strong problem solving, trouble shooting, and analytical skills
•Advanced technical writing skills
•Able to balance complexity between innovation and regulation
•Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
•Constructively progress to outcomes despite uncertainty or ambiguity 
•Drive change, efficiency, and strong cross-functional relationships
•Excellent verbal and written communication
•Lead and motivate a team
•Ability to drive continuous improvements                                                                                                                                                                   
•Ability to Influence                                                                                                                                                                                                           
•Command / seen as owner of their program                                                                                                                                                                
•Excellent communication to all levels of the organization                                                                                                                                        
•Supervisory skills                                                                                                                                                                                                               
•Able to manage resources                                                                                                                                                                                                  
•Able to apply strategic and critical thinking                                                                                                                                                               
•Able to perform with a Global mindset                                                                                                                                                                           
•Able to identify solutions                                                                                                                                                                                                     
•Ability to deal with ambiguity
Experience Required
•7+ years of quality and manufacturing experience in biotech or pharmaceutical industry
•Bachelor's degree in a Science field
•Deep and broad understanding of quality processes including change control, design controls, risk assessment and 
       management, and root cause analysis.
•Deep combination product expertise and experience including functional knowledge of applicable guidance, 
       regulations and standards to enable future compliance as projects enter into design controls
•Strong knowledge of quality engineering and device engineering
•Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics
•Strong problem solving, trouble shooting, and analytical skills
•Advanced technical writing skills
•Able to balance complexity between innovation and regulation
•Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
•Constructively progress to outcomes despite uncertainty or ambiguity 
•Drive change, efficiency, and strong cross-functional relationships
•Excellent verbal and written communication
•Ability to drive continuous improvements         
•Ability to Influence and demonstrate strong command / seen as owner of their program     
•Excellent communication to all levels of the organization              
•Supervisory skills and/or demonstrated ability to lead without direct authority  
•Experience driving decision making by using DAI principles
•Able to manage resources     
•Able to apply strategic and critical thinking   
•Able to perform with a Global mindset                                                   
Roles & ResponsibilitiesKey Responsibilities:
•Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non- 
        combination products associated with Final Product Technologies activities. 
•Attend development program meetings as required as part of program working teams. 
•Work cross-functionally with individuals and project teams to ensure success of development project efforts. 
•Provide guidance on documentation structures created during development activities. 
•Identify proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design 
        and development process to ensure compliance with applicable regulations and Procedures. 
•Provide input to the Design and Development Plans for projects, and review and approve relevant combination 
        product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, 
        Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, 
        Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration 
        specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), 
        Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated 
        projects. 
•Actively participate and contribute to applicable Design Control Phase Design Reviews. 
•Provide Quality oversight of Design Characterization and Verification and Validation activities. 
•Ensure adherence to all relevant regulations and standards based on the type of device under development. 
•Represent FPTQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of 
        supplier qualification and development as it relates to design control activities. 
•Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal 
        written responses. Participates in audits and inspections, is well prepared by owning relevant details that are 
        supported by evidence and for associated projects. 
•Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, 
        fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems. 
•Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s). 
        Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk 
        Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) 
        Protocols and Reports, as well as onboarding and auditing HFE suppliers

Brian K. Kubiak, Sr. Technical Recruiter, The Judge Group

Direct Dial: 732.497.4294 | Email: [Click Here to Email Your Resumé]

linkedin.com/in/brian-k-kubiak-3593983

Click to learn more about Judge’s TechnologyTalent & Learning Solutions

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Contact: [Click Here to Email Your Resumé]

This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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