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Supplier Quality Engineer

Alcresta Therapeutics develops novel products that deliver enzymatic solutions to those living with rare diseases. Based in Massachusetts, Alcresta Therapeutics has achieved significant commercial milestones, created an extensive intellectual property portfolio, optimized production capabilities, and developed exciting scientific data supporting its products and technology platform.

We are seeking a Supplier Quality Engineer to support activities relating to Supplier Quality Management, especially for contract manufacturers. Assist the R&D and Technical Operations groups with the issues relating to supplier selection, development, qualification, process validation and supplier assessment activities during design control and manufacturing.

Responsibilities

  • Support the organization with the selection, qualification and on-going assessment of new and existing suppliers, including contract manufacturers.
  • Provide relevant quality support to R&D and Technical Operations (Tech Ops) group towards the development and maintenance of critical suppliers during new product introduction and routine production.
  • Perform quality system gap assessment of critical suppliers, as necessary. Review quality system documentation associated with the supplier.
  • Collaborate with the Tech Ops and the supplier during design verification and validation and transfer to commercial production.
  • Escalate supplier quality issues to the Management, as needed and collaborates with Tech Ops group towards taking appropriate actions with the supplier to address the quality-related issues during routine production.
  • Support Tech Ops group to identify and eliminate risks that could impact the product quality. Participates in risk assessment activities to identify product quality and compliance risks, and to mitigate those risks.
  • Performs 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 supplier-initiated deviations/variances, non-conforming material and its disposition, associated investigation according to agreed-upon plan and escalation to SCAR, as necessary. Monitor the progress of Supplier Corrective Action Requests (SCARs) and their timely closure with the supplier.
  • Support Tech Ops group on validation activities at the contract manufacturers including review/approval of process qualification plans, PFMEA, Control Plans, and associated reports.
  • Represent QA group in discussions related to supplier quality during new product introduction, and supplier periodic review during commercial production.
  • Collaborate with Tech Ops and Supply Chain groups to manage suppliers through the review of supplier performance metrics and associated improvement plans.

Education and Experience

  • Bachelor’s Degree in Science or Engineering
  • 5+ years of experience in supplier quality management and/or quality assurance in medical device or related life science industry, including minimum of 3 years of experience in GMP environment a must
  • Experience in chemical/biological manufacturing processes and methodologies preferred
  • Medical Device Auditing experience is preferred

Key Skills and Competencies

  • Familiarity with supplier controls, risk management, and process validation associated with medical device or pharmaceutical products.
  • Knowledgeable on ISO13485:2016, FDA 21 CFR Part 820 and ISO 14971:2019 Risk Management requirements.
  • ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification preferred.
  • Ability to work in a cross functional team as well as the ability to be a self-starter and motivated to work independently.
  • Demonstrated ability to liaison with engineering and manufacturing resources
  • Working knowledge of Root Cause Investigation, CAPA, pFMEA and statistical techniques/data analysis.
  • Working knowledge in chemical/biological processes, injection molding and mechanical assemblies etc.

Other requirements

  • 20-35% travel (including international)
  • Candidates must be fully vaccinated