RE: Experienced Quality Engineer/Manager (CLIA/Diagnostics) – RTP Biotech/Will Relo

Job Type: 
Life Sciences
Quality Assurance and Quality Control
Scientific Research and Lab Operations
Data Management, Biostatistics and Programming
Other Life Science Positions
Employment Category: 
Direct Hire

Our client, a venture-backed developer of cutting-edge genomic amplification technologies, is expanding its team and actively recruiting for an exceedingly sharp, knowledgeable and can-do candidate to drive all Quality functions. 

This is a critical role for the company and requires an outstanding candidate.  Company will offer rich compensation package (including generous equity offerings) to attract and retain a star.

Key Things to Note:

  • This company is bringing new solutions for cellular heterogeneity in both the research and clinical space studies
  • It manufactures commercially-available kits that contain the enzymes and reagents needed for versatile and scalable whole genome amplification as well as offers lab services for genomic analysis. We seek a candidate who brings Quality expertise for both product and service.  CLIA knowledge would be valuable.
  • This is a start-up setting.  This Quality Engineer/Manager (client is open to both levels), in conjunction with the COO, will be establishing Quality practices and systems for the entire organization.  We seek a candidate who will thrive in this building environment.
  • This position will begin as a hands-on, individual contributor - with high growth potential.  We seek a Subject Matter Expert with a strong tactical and strategic mindset and work style.
  • This position is on-site at the company’s offices in Research Triangle Park, NC.  Relo support will be provided.

The focus of the role will be to establish, implement and maintain rigorous and appropriate Quality Systems for the design and manufacture of novel genome amplification applications.

Selected Responsibilities:

  • 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. Own and/or coordinate CAPAs and NCRs.
  • Provide Quality support in the assessment and qualification of new suppliers and materials including specifications and inspection standards.
  • Conduct Audits of contract manufacturing partners and suppliers.
  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
  • Review verification and validation reports; Identify gaps for compliance to Quality requirements; Develop and execute strategies to close Quality gaps
  • Trend, analyze, and report on Quality data in order to improve product and process; develop recommendations based on data analysis.

Targeted candidate will offer a BS/MS scientific degree and 7+ years of Quality Assurance experience in a life sciences or medical device setting. 

Other priorities include:

  • Experience and success building Quality programs in a start-up setting
  • 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)
  • Experience with CLIA Certification
  • Record of impact and growth

Finally, we seek an industrious and self-directed candidate who will be a significant contributor to this company that is doing innovative work in a critically-important field; A candidate who can thrive without a roadmap and will bring the knowledge, savvy and drive to work through ambiguity and complexity to achieve desired results.

This is an immediate need.  Please forward Word resume for prompt consideration.