Facilitate collaboration across various company functions in areas such as design and development projects, product and process modifications, risk management, root cause investigations, validations, process capability assessments, trend analysis, and statistical process improvement.
Develop, enhance, implement, and sustain Quality Management procedures to efficiently meet customer, technical, and regulatory requirements while aligning with company goals. Drive initiatives to reduce manufacturing defects and enhance quality systems.
Act as a representative of Quality Engineering in design and development activities from inception to product launch, including product and process changes, ongoing safety and efficacy in the market, and post-market surveillance efforts.
Provide subject matter expertise and ensure the generation of objective evidence adhering to scientific methodology, encompassing areas like product and process development, specification development, design transfer, design validation, process validation, risk management, product realization, packaging and shipping validation, product launch, and nonconformance assessment.
Maintain QMS procedures that support risk management activities and create audit-ready risk file documents in compliance with international risk management standards and regulations.
Independently review and evaluate change orders, assessing the scientific approach, presence of supporting objective evidence, technical validity, accuracy, completeness, and compliance with applicable regulations and standards. Offer guidance on identified gaps and collaborate to determine remediation measures.
Employ critical analytical thinking during root cause analysis, risk assessment evaluation, and determination of corrective and preventive actions to ensure thorough gap resolution.
Provide concise Quality input into process investigations with a systematic approach to address root causes and CAPAs.
Analyze defined quality metrics and quality-related data to identify issues or trends.
Identify relevant processes for new standards and regulations, ensuring departmental records, QMS procedures, and controlled documents align with applicable regulations and standards.
Assist in designing and documenting new and revised quality systems for product realization in compliance with relevant regulations and standards.
Maintain audit readiness for QMS processes, procedures, and quality documentation. Escalate events that may impact the safety or efficacy of medical devices and address and remediate events affecting QMS processes or effectiveness.
Support other functions in resolving quality systems issues and concerns.
Provide support for internal and third-party audits, prepare for regulatory inspections, and participate in audit execution.
Assist in closing audit findings by offering quality guidance for investigations and implementing necessary corrections and corrective actions/preventative actions.
Ensure compliance with standard operating procedures (SOPs), ISO, FDA, and other Quality System regulations, as well as relevant Environmental Health & Safety, Human Resources, and all other regulatory and administrative policies.
Minimum Knowledge & Experience required for the position:
Education
Bachelor's degree in a life science, engineering, or equivalent, required. Advanced degree preferred.
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) Qualifications
Eight (8) or more years of work experience in IVD or medical device industry required.
Six (6) years 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 required.
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).
Advanced knowledge in various areas, including design controls, risk assessment, root cause investigations, trend analysis, statistical sampling, change control assessment, nonconformance assessment, design of experiments, project management, and data mining.
Advanced expertise in Process Quality Engineering, Supplier Quality Engineering, Design Quality Engineering for laboratory instruments (hardware, consumables, and software), Design Quality Engineering for IVD assay reagents, Design Quality Engineering for IVD system integration, and Risk Quality Engineering.
Advanced ability to interpret and apply compliance and quality management requirements.
Advanced ability to manage multiple tasks in a fast-paced environment, both as a team member and individually, with accuracy and timeliness.
Advanced ability to function effectively in a changing environment with ambiguity.
Advanced skills in influencing, negotiation, building collaborative relationships, and maintaining positive working relationships.
Advanced problem-solving skills, with a proactive and creative approach.
Advanced skills in verbal and written communication, including technical writing.
Proficiency in Microsoft Office Suite: Word, Excel, Access, Outlook, PowerPoint, Visio, and Adobe Acrobat.
