Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective actions.
Aides in the assessment and qualification of new supplier materials such as component specifications and inspection standards
Participates in supplier audits to drive process standardization and continuous improvement
Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders
Provide consultation to end users and process owners with regard to data collection, analysis and creation of validation reports.
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for GMP compliance. Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Identify areas and opportunities to improve quality system processes
Ensure product development and validation programs meet requirements of FDA and ISO
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion
Own and/or coordinate all SCARs
Directly support projects/investigationsassociated with supplier quality
Track and trend supplier performance and recommend appropriate actions
Collaborate with the procurement, purchasing, and product design groups to assure compliance/quality of new vendors/materials
Function as a liaison between global supplier quality and operations
Other activities as assigned
5- 8+ years’ experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred.
Quality Certification preferred (e.g., CQE)
Experienceapplying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, and ASTM E2500-07 Verification Guideline) Practical experience in design controls, risk management, validation, change control, and supplier quality
Experience with CAPA and failure investigation tools and techniques
Appliedexperience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
Highly effective communication, facilitation, coaching, and negotiation skills
Adaptable to fast-paced, dynamic work environment with shifting demands
Demonstrated ability to accomplish goals while working across departments is required
Bachelor’s degree in an engineering or science discipline; advanced degreepreferred