JOB SUMMARY

The Staff Quality Engineer works with cross-functional teams with the goal of ensuring and maintaining product safety and efficacy. The position uses technical knowledge and experience to ensure strategies for product and processes meet regulatory and business objectives. This role advises management on systems and techniques to maintain efficient and compliant systems.

KEY ACCOUNTABILITIES

• Teamwork: Is Quality Engineering lead on design and development projects, product and process changes, risk management, root cause investigations, validations, process capability, and trend analysis. Provides team with strategic and tactical guidance related to Quality Management procedures for design and development, production, and post-production (post market) activities. Drives improvement projects and initiatives that reduce systemic manufacturing defects; improve quality systems. Independently lead multiple long-term projects. Interact with supervisor as required on activities, issues, or turning points. Models effective team dynamics behavior. Encourages and empowers others to achieve project outcomes. Provide training and guidance to junior members of the team.
• Product and Process Life Cycle: Represent Quality Engineering in Design and Development activities through launch, Product and Process Changes, sustaining On-Market safety and efficacy, and Post-Market Surveillance endeavors. Provide Quality-consensed subject matter expertise and ensure the delivery of objective evidence using scientific methodology which is technical validity, accuracy, complete, and comply to applicable regulations and standards in QMS areas such as product and process development, specification development, acceptance methods development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment.
• Risk Management: Acquire and maintain current knowledge of applicable requirements for risk management activities and produce audit ready Risk File documents in compliance with the requirements of current international risk management standards and regulations. Coordinate evaluation of new and emerging risk standards Assist in the development of plans for meeting and complying with new risk regulations, guidances, and standards.
• Quality Science and Engineering: Perform independent quality review and evaluation of change orders including related data for scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance to applicable regulations and standards. Provide guidance on identified gaps and collaborates to determine remediation activities. Apply critical analytical thinking in the investigation process specifically during root cause analysis, risk assessment evaluation and determination corrective and preventive actions determination to guarantee gaps are properly addressed. Provide consensed Quality input into process investigations using a systematic approach to ensure root causes and CAPAs are aligned. Collect and analyze defined quality metrics, quality-related data to identify issues or trends.
• Quality Engineering Strategic and Tactical Management. Assist Quality Engineering management with development of strategic and tactical options for accomplishing company goals and initiatives. Implement assigned strategies and tactics. Manage Quality Engineering consultants when engaged to assist with goals.
• Quality Management Systems: Identify applicable processes for new standards and regulations. Ensure departmental records, QMS procedures, and controlled documents comply with applicable regulations and standards. Aid in designing and documenting new and revised quality systems for product realization compliance with applicable regulations and standards. Ensure QMS processes, procedures, and quality documentation to maintain a state of audit readiness. Escalate events that may contribute negatively to medical devices safety or efficacy. Address and remediate events that may contribute negatively to QMS processes or effectiveness. Apply critical analytical thinking in the investigations and nonconformance systems specifically during root cause analysis, risk assessment evaluation, and corrective and preventive actions determination to guarantee that (potential and actual) nonconformances are properly addressed. Support other functions in resolving on quality systems issues and concerns.
• Audit: Support internal, and third-party audits, regulatory inspection preparation and execution. Assist in closing audit findings by providing quality guidance for investigations, and implementation of resulting corrections, and/or corrective actions/preventative actions.
• Ensure compliance with applicable Inova standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.
• Reflect the values of Werfen and Inova in the quality of work and in working relationships.
  Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

MINIMUM KNOWLEDGE & EXPERIENCE FOR THE POSITION:

Education:

• Bachelor’s degree in a life science, engineering, or equivalent required. Advanced degree preferred.
• Six Sigma/Lean Black Belt certification, preferred.
• ASQ Certifications for Certified Quality Engineer, (CQE), Certified Supplier Quality Professional (CSQP) Risk Management Specialized credential, or Quality Manager (CQM) preferred.

Experience:

• Ten (10) or more years of work experience in IVD or medical device industry required
• Seven (7) year of work experience in Quality Engineering in the designated specialty of Process Quality Engineering, Supplier Quality Engineering, Design Quality Engineering for laboratory instruments (hardware and software), Design Quality Engineering for medical software, Design Quality Engineering for IVD assay reagents, Design Quality Engineering for IVD system integration, Risk Quality Engineering, or related functions.
• Project management experience preferred.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

SKILLS & CAPABILITIES:

• Advanced knowledge of current compliance requirements (e.g., US Quality System Regulations (QSRs), EU in vitro Diagnostics Regulations (IVDR), ISO 13485, ISO 14971, ISO 17025, IEC 60825 or other regulations and standards) and advanced ability to interpret and apply compliance and quality management requirements.
• Advanced knowledge in design controls, risk assessment and analysis, root cause investigations, trend analysis, statistical sampling, change control assessment, nonconformance assessment, design of experiments, project management, data mining, requirements analysis, and traceability.
• Advanced knowledge of both hardware and software engineering principles, as well as the specific requirements and challenges associated with IVD systems, including assays. Familiar with various diagnostic platforms and the protocols that facilitate communication between them. Knowledgeable in systems integration including designing robust validation and verification processes and troubleshooting.
• Working knowledge of fluidics in diagnostic devices, including understanding the principles of fluid dynamics and how they apply to the operation and integration of fluidic systems within diagnostic instruments.
• Working knowledge in mentoring and technical development of junior staff.
• Advanced ability to function effectively with ambiguity in a rapidly changing environment to organize and complete multiple tasks as a team member and/or as an individual contributor in a timely, accurate manner under general supervision.
• Advanced abilities in influence and negotiation while building collaborative relationships and maintaining strong, positive working relationships.
• Advanced ability to develop proactive and creative approaches to problem solving.
• Advanced skills in verbal and written communication including technical writing.
• Advanced skills in Microsoft Office Suite: Word, Excel, Access, Outlook, Power Point, Visio, and Adobe Acrobat.
  Travel requirements:If required, provide approximate percentage of travelling time.