Careers at Alcresta Therapeutics
Senior Quality Engineer
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.
- 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.
- ~20% travel (local/domestic/international).
- Candidates must be fully vaccinated.