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Senior Quality Systems Manager

Department: Operations
Office or Remote: Remote
Location:
Business Unit: Pandemic Response Lab (PRL)

Location: Remote*

*Must be located in one of the following states:  CA, CO, CT, FL, IL, MA, MD, MN, NJ, NY, OR,PA, TX, UT,VA, WA or Washington DC

About Us
Opentrons Labworks, Inc., is a disruptive life science company leveraging its integrated lab platform to supercharge the pace of innovation in research and healthcare. Through our business unit, Opentrons Robotics, thousands of institutions are automating R&D operations with flexible, easy-to-use lab robots. Health systems across the US rely on our Pandemic Response Lab (PRL) to deliver high-throughput and affordable molecular diagnostic testing. And through recent acquisitions Neochromosome and Zenith AI, biopharma can benefit from our world-class genome-scale cell engineering solutions. 

We provide excellent benefits, competitive compensation, equity packages, and opportunities for growth. If you are looking for your next exciting opportunity, come join us!

Benefits

  • Comprehensive Medical, Dental and Vision insurance for employees and their families

  • Paid Vacation, Parental and Sick Leave

  • Generous Stock options

  • 401k with 4% company match

  • Long-term and short-term Life & Disability insurance

  • And much more!

About The Role

The Sr. Quality Systems Manager is responsible for the development, implementation, continuous improvement, and sustainment activities of the Quality systems programs, processes, and procedures for Non-conformance (NCR), Corrective and Preventive Actions (CAPA Process), Customer complaints, and Post-market Surveillance (PMS) programs.

Responsibilities 

  • Provide QA oversight of nonconforming product and materials (NCR process), and Corrective and Preventive Actions (CAPA process), Customer Complaints, and Post Market Surveillance Program (PMS)
  • Support in the maintenance and implementation of the Quality Plan to ensure Quality Objectives and the Quality Policy are met
  • Manages and provides oversight to multiple, complex NCR and CAPA investigations and drives completion of the associated quality documentation within the appropriate time frame. Establish processes to trend performance over time
  • Ensure compliance with all relevant ISO CLIA, CAP, NYSDOH, ISO 15189 and provide training to staff
  • Active participant and contributor to support change control process and associated verification and validation documentation associated with complex issues.
  • Provide Quality assessment of changes to production processes, materials, design and procedures and ensure applicable and appropriate documentation
  • Familiar with application and use of risk management documentation (product hazard analysis, pFMEA) and use of risk management techniques
  • Represent Quality Assurance and interacts with cross-functional departments to provide quality guidance
  • Responsible for collating information to support the quarterly Quality Management Review. Establish regularly scheduled updates with cross functional departments to collect the quality metric data to support the QMR
  • Establish processes to monitor and trend CAPAs, NCRs, Deviations, SCARs, change control, and assay release activities
  • Responsible for managing automation of NCEs, CAPA, Complaints processes in Greenlight guru . Establishes continuous improvement projects to facilitate operations support activities
  • Provides oversight to the review and closure of customer complaints and the associated quality documentation within the appropriate timeframe. Establish processes to trend performance over time
  • Manage audit findings and establishes continuous improvement tools based on assessment of the audit data
  • Prepares site for internal and external inspections and directly interfaces with auditors/inspectors, (CAP, NY State and States applications and inspections).
  • Administer  Quality Systems training for new hires Maintains and coordinates communications between cross-functional teams.

Qualifications 

  • Bachelorís degree in a physical, chemical, biological, or clinical laboratory science and 7+ years in high complexity testing in CLIA/CAP environment;
  • Solid knowledge of CAP, CLIA, New York State's regulations, ISO 15189, including successfully having completed multiple CAP inspections.
  • A minimum of 5 yrs experience of hosting audits and direct interaction with CAP/NYSDOH and/or other regulatory agencies.
  • Experience writing, evaluating and closing investigations, CAPAs and change control records
  • Experience with EQMS systems process automation and implementation desired
  • Willingness to think outside of the box and adapt best practices to this small, but growing environment.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies.
  • Experience with test plan development and root cause failure analysis, and risk assessments
  • Knowledge and application of Quality tools and methodologies (e.g., lean six-sigma)
  • Has a proven track record of delivering results and is action-oriented.
  • Must be able to work in a biohazard environment and comply with safety policies and standards outlined in the Safety Manual.

Opentrons is an equal opportunity employer and does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

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