Quality Assurance Engineer- Design controls

Posting ID : A1068475025
Date Posted : 2015-08-18
Category : Architect Engineer Cad

Description

Support product development programs (new and sustaining). Lead proactive design assurance activities facilitating the development and release of high quality products. Ensure standard and process compliance. Provide investigative support/leadership when significant product quality issues arise. Emphasis is placed on knowledge of standards, regulations, investigative/root cause processes, and procedures supporting compliance to industry, Healthcare (PH), and Computed Tomography/ Advanced Molecular Imaging (CT/AMI) product quality norms/requirements. Provide technical expertise in the area of design assurance to Engineering, Operations, Customer Service and Field Service personnel.

Your Responsibilities:

Design Quality Assurance
Integral member of product development team responsible for supporting activities required to ensure reliability of the design through compliance with design controls
Provide guidance of Design Controls and the Product Realization Process (PRP) to the engineering core teams
Key deliverable is to support and/or develop the Quality Plan or Quality Planning documentation for each program and project assigned
Identification of procedure/revision or other method to be used for each deliverable
Work closely with product development engineering, clinical, marketing and regulatory to assure appropriate reliability requirements are defined for the specific device application and target patient population
In collaboration with product development, recommend/promote new testing methodologies and approaches required to complete reliability analysis of device designs
Participate in the review of clinical relevant test methods and Design Verification test plans, execution and reports as required
Work with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability and reliability. Provide guidance for development of manufacturing test/evaluation methods and process validation.
Works with Program Manager on Risk management activities including supporting and leading Failure Mode and Effect Analysis (FMEA) /Risk Management activities and essential requirements analysis including standards review and evidence of conformity.
Ensure that checklist items for their business function in the Milestone Review Procedure are completed for each PRP phase
Ensure completion of the functional actions items /tasks and submission of deliverables to the document control system. Report on functional group progress and issues to team (including escalation and program review)
Supports audits and compliance assessments of the Design History File (DHF) and other program files to ensure quality and regulatory requirements are met and audit findings appropriately addressed
Ensuring DHF completeness as appropriate or required
Participates in the Defects Classification, Defect-Risk Analysis forum and IR investigations
Participates in all design, validation, defect classification and documentation reviews as required
Responsible for tracking and ensuring defect closure for their function
Responsible for ensuring their functional Engineering Change Orders (ECOs) and Document Change Orders (DCOs) are released
Support Post Market Product Assurance and audit groups in post-market activities
Work with a cross-functional, collaborative, team-based environment; work with multiple sites in various locations, time zones, and countries
Identify, manage and notify program team of inter-dependencies with other functions
Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development.
Provide clear and regular technical and administrative input to professional, technical and administrative personnel assigned to a project. Execution and Productivity
Documents, releases, and maintains Design Controls Quality Assurance deliverables and documentation subject to review and approvals, according to project plans and schedules.
Assignments given normally have clear and specified objectives and require the investigation of a limited number of variables and resolve routine issues. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Displays adequate time management skills, but may have some trouble with deadlines. May need help with long term estimates.
Learns quickly but may require some guidance and instruction from more senior quality assurance engineers. Process Improvement & Functional Excellence
Completes work and activities in compliance with the Quality Management Systems (QMS) processes and PRP procedures.
Ensures deliverable quality by applying design controls quality assurance department best practices, guidance, and standards routinely.
Contributes to design solutions and technologies that improve reliability, manufacturing, serviceability, sustainability, and reduce costs.
Actively contributes and participates in continuous process improvement activities within the quality assurance and engineering department or organization. Teamwork & Communication
Acts as individual contributor.
Interaction is primarily internal. Any interaction with outside groups is limited and closely supervised Groups can include: including engineering, regulatory, suppliers of materials, contractors (individuals or companies), testing facilities, manufacturing, sourcing, and service in order to fulfill project needs and assure compliance.
Must be open-minded and accept input from team members and other senior personnel.
Communicates status, results, or issues in a timely and professional manner, and escalates problems or roadblocks appropriately when necessary.
Collaborates with other team members or domain experts to achieve compliant quality results.

Requirements:

Bachelor's degree in engineering or science discipline
3-7 years related work experience with exposure to medical, aerospace, or defense products
Mastered regulatory compliance awareness, including at a minimum FDA design controls: MDD, 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304
Design assurance and design quality
Static verification, design verification, and design validation
Defect management
Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
Experience in reliability characterization and demonstration test methods, including establishing relevant test parameters and test sample sizes
Demonstrated experience and understanding in use of statistical tools
Proven experience as a contributing member of a team to take design from concept into production
Ability to learn quickly and respond to changing priorities
Must have strong interpersonal communication skills as well as being a motivated team player Good verbal and written communication skills, good team skills including project management
Technical writing and presentation skills
Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project)

Requirements:

Bachelor's degree in engineering or science discipline
3-7 years related work experience with exposure to medical, aerospace, or defense products
Mastered regulatory compliance awareness, including at a minimum FDA design controls: MDD, 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1, IEC 62304
Design assurance and design quality
Static verification, design verification, and design validation
Defect management
Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of moderate scope and complexity
Experience in reliability characterization and demonstration test methods, including establishing relevant test parameters and test sample sizes
Demonstrated experience and understanding in use of statistical tools
Proven experience as a contributing member of a team to take design from concept into production
Ability to learn quickly and respond to changing priorities
Must have strong interpersonal communication skills as well as being a motivated team player
Good verbal and written communication skills, good team skills including project management
Technical writing and presentation skills
Experienced with basic PC skills (MS Word, Excel, PowerPoint, and Project) Desired/Preferred Qualifications
CRE / CQE Certification Design for Lean Sigma (DFLS) / Six Sigma / Design for Reliability and Manufacturing (DRM) experience
Working knowledge of FEA simulation tools and analysis
Minitab experience
Strong statistics background Experience with medical device regulations


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