Quality Engineer (Pharma Glass)
Our client, a FORTUNE 500 world-leading supplier of high-quality glass tubing to the pharmaceutical packaging industry, with operations in the USA and Europe, manufactures a variety of clear and amber borosilicate glass tubing, that is converted into vials, cartridges, ampoules and syringes for drug storage. (FDA industry experience NOT REQUIRED)
Scope of Position:
The Quality Engineer will apply knowledge of engineering principles and practices to effectively implement the Company’s Quality Management system goals and initiatives.
- Develop and implement systems and procedures required to successfully meet division and corporate goals and objectives.
- Effectively take action when non-conformances are found.
- Ensure that documented practices meet the true interpretation of the Quality Management System and ISO requirements.
- Act as the Plant ISO Management Representative.
- Create, maintain, and execute the Company’s global Quality Systems strategy
- Facilitate efforts in understanding processes capability and product quality architecture.
- Facilitate root cause analysis on products and processes not meeting specified standards and requirements.
- Act as Quality Representative at Customer Review meetings.
- Track customer complaints, due dates, open issues, and investigation status.
- Finalize complaint responses in conjunction with department owners.
- Work cross-functionally on a daily basis to accomplish goals.
- Work with process engineering to identify and implement improvement opportunities and corrective/preventative actions.
- Perform audits of existing plants and processes to determine compliance to facility’s Quality Management System and ISO requirements.
- Collaborate with Engineering and Manufacturing functions to ensure quality standards are in place.
- Participates in the governance of Quality Management System processes.
- Ensure high level of competence in quality systems globally.
- Lead Quality roadmap improvements.
- Certified in LEAN and Six Sigma quality engineering methodologies.
- Participate in Six-Sigma projects, assuring the effective use of different improvement methodologies (DMAIC, Lean, DESGN, PQA, etc.).
Desired Years and Area of Experience:
5+ years of experience in Manufacturing, Engineering and/or Quality. (FDA industry experience NOT REQUIRED)
BS/MS Engineering Degree or Science Degree.
- Statistical competency; understands variability, sampling methods.
- Problem solving skills to drive to root cause (e.g., KT).
- Solid communication skills (written, verbal, presentation); project management skills.
- Familiarity with Quality Systems, audits, TL and ISO Certifications or other types of Quality certifications.
- MS Office with strong Excel and PowerPoint skills.
- Minitab, JMP, or similar analysis tools.
Paid relocation to vicinity of Greater Philadelphia, PA area
Competitive Salary ($80,000 - $90,000+) plus bonus.