Careers at Alcresta Therapeutics

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Senior Quality Engineer

Overview

Perform various quality system activities towards maintaining the effectiveness of Alcresta QMS, compliant with applicable requirements for medical devices. Assist the R&D and Technical Operations groups with supplier selection, development, qualification, periodic assessment and process validation activities during design control and manufacturing.

Responsibilities

  • Perform quality system activities related to CAPA, Non-Conforming Management, Supplier Control and Design Control, as needed.
  • Perform related root cause investigation associated with CAPA and NCRs working with the CAPA team and assist the team in their successful implementation and closure.
  • Create/review new or existing quality system documents, as applicable and manage changes associated with them.
  • Support the organization with the selection, qualification and on-going assessment of new and existing suppliers, including contract manufacturers (CMOs).
  • Provide relevant quality support to R&D and Technical Operations (Tech Ops) group during new product development as part of Design Control.
  • Support the development and maintenance of critical suppliers during new product introduction and routine production. Provides quality related guidance to critical suppliers, which are under development, as necessary.
  • Perform Supplier Approval and quality system audits of new and existing suppliers, as needed. Follow up on timely closure of supplier audit findings.
  • Collaborate with Tech. Ops. team to review CMO-initiated Deviations/variances, Non-Conforming material and its disposition, associated investigation according to agreed upon plan and escalation to CAPA, as necessary.
  • Collaborate with Tech. Ops. and Supply Chain groups to manage CMOs through the review of performance metrics and associated improvement plans.
  • Support various group to identify and eliminate risks that could impact the product quality. Participates in risk assessment activities to identify product quality/compliance related risks, and to mitigate those risks.
  • Support Tech Ops group on validation activities at the CMO sites, including review/approval of process qualification plans, PFMEA, Control Plans, and associated reports.
  • Up to 20% travel may be required (subject to COVID travel restrictions).

Education and Experience

  • Min. Bachelor’s Degree in Life Sciences, Chemistry or Engineering.
  • 3-5 years of experience in quality management and/or quality assurance in medical device or life science industry; experience in Drug, Biologics or Medical device GMP environment required.
  • Experience in manufacturing processes and methodologies; chemical/biological industry related experience preferred.

Key Skills and Competencies

  • Familiarity with CAPA, Non-conformity Management, Supplier control, Risk management, and Process Validation associated with medical device or pharmaceutical products.
  • Familiarity with ISO13485, FDA 21 CFR Part 820 and ISO 14971 Risk Management requirements.
  • ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) or similar certification preferred.
  • Ability to work in a cross functional team as well as the ability to be a self-starter and be motivated to work independently.
  • Demonstrated ability to liaison with engineering and manufacturing resources.
  • Working knowledge of Root Cause Investigation, CAPA, FMEA and statistical techniques/data analysis.
  • Working knowledge in chemical/biological processes, injection molding and mechanical assemblies etc.
  • Possess conceptual and analytical thinking, ability to write clearly and review content of design and validation documentation.
  • Strong communication, teamwork, and organizational skills; Strong analytical and problem solving skills.
  • Proficiency in computer technology and systems operation.

Other Requirements

  • ~20% travel (local/domestic/international).
  • Candidates must be fully vaccinated.