Senior Quality Engineer

Bioskryb is seeking a Senior Quality Engineer to join their team and establish and implement quality systems for the design and manufacture of novel genome amplification applications. The ideal candidate will have 7-10 years of experience in quality assurance working in the life sciences or medical device industry with a BS or MS degree. They will be responsible for providing ongoing quality engineering support, establishing a process to ensure adequacy of complaint, non-conformances and CAPA records, and identifying areas and opportunities to improve quality system processes and product issues. The candidate should have experience with quality regulations and standards, design controls, risk management, validation, change control, and supplier quality.

• Provide ongoing quality engineering support throughout the product life cycle for new single cell products based on our core technology, Primary Template Directed Amplification (PTA)
• Provide support to the R&D and manufacturing teams for the validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Provide quality support to engineering change controls, deviation management, and document change management.
• Asist with the development and implementation of a QMS.
• Establish a process that ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective/preventative actions.
• Provides quality support in the assessment and qualification of new suppliers and materials including specifications and inspection standards.
• Conduct quality audits of contract manufacturing partners and suppliers to insure the highest level of product.
• Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
• 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 compliance to internal quality requirements.
• Establish a dashboard with the appropriate KPI’s.
• Develop and execute strategies to close quality 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 and product issues.
• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
• Own and/or coordinate CAPAs and NCRs.

• Experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, IVDR, MDSAP, 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
• Applied experience with quality and statistical analysis tools (e.g., SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis)
• Adaptable to fast-paced, less structured, dynamic work environment with shifting demands
• Demonstrated ability to accomplish goals while working across departments is required.
• Experience with CLIA Certification
• 7-10 years’ experience in quality assurance working in the life sciences or medical device industry with a BS or MS degree
• Demonstrated experience implementing quality systems in a startup environment.
• Experience in Genomics, Immunology, Biology, or a relevant field preferred.