- Posted: over a month ago
Provide technical and compliance analysis for product and process for quality related functions such as Nonconformance, Complaints, CAPA, and Change Record Management. This role supports tech transfer, manufacturing, and process/product improvement of bioreactors and single-use products. Knowledge and experience with engineering and technical methods as well as the Quality Management System (QMS) is required. Additional leadership and project assignments will be assigned based on evolving needs of the business.
Job Duties and Accountabilities:
- Provide technical and Quality Engineering analysis and assessments for impact to product quality, comparability, and root cause analysis to support change orders, nonconformances (investigations), CAPA, validation/verification, and manufacturing processes.
- Perform or manage corrective actions to support CAPAs, maintaining and revising Quality Systems documents, to include but not limited to manuals, procedures, work instructions, forms, etc.
- May be assigned to perform QA approvals, including ensuring that corrective measures meet acceptable criteria or standards, and that documentation is compliant with QA requirements.
- Quality Owner for CAPA or Change Records of manufacturing process and equipment as a result from NCs or Complaints and meeting QMS record deadlines.
- Responsible for continuous improvements of assigned processes. Identify opportunities for and lead or participate in continuous improvement of the QMS program, which may include seeking feedback from stakeholders.
- Liaise between the Engineering and Quality departments to provide support of Engineering projects and to identify and coordinate improvements.
- Supports or manages procedure updates and improvements.
- Will be assigned additional tasks and projects as needed to meet business objectives.
Required Education and Experience:
- A bachelor’s degree in an Engineering discipline or related science field with ≥ 3 years of relevant industry experience.
- Minimum 2 years in a Quality Engineering or 3 years in a related role such as Commercial Product Engineering, Manufacturing Engineering, or Industrial Engineering or similar role.
- Minimum 2 years of experience working in a quality system with products regulated by GMP/Biopharma (21 CFR 210/211, ICH Q7/10) or medical device (ISO 13485), or similar medical products field.
- Advanced skills with MS Office applications Word, Excel, as well as Adobe Acrobat.
- Experience interfacing with engineers to perform tech transfer, data analysis and statistical methods, verification/validation.
- Excellent verbal and written communication skills including excellent technical writing skills.
Preferred Education and Experience:
- Bachelor’s degree or higher in an Engineering and Quality field.
- Experience with a quality management system in drug/biotech/pharma (21CFR210/211), medical devices (21 CFR 820, ISO 13485/14971) or medical products (ISO 9001, ISO 13485).
- Experience with polymer processing – injection molding, machining, and extrusion.
- Experience with assembly and testing of medical products or drug product manufacturing.
- Experience with product development, tech transfer, and manufacturing process control.
- Experience with software, computerized systems, and/or control system validation.
- Experience using one or more engineering tools and methods such as CAD, statistical analysis (Minitab, JMP, SigmaXL, SAS, R, Matlab, Dataplot, or equivalent), statistical sampling/acceptance methods (ANSI, MIL-STD, AQL), design of experiments, design control, DFM, etc.
NXTThing RPO is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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