Job Function Summary:
Monitor and maintain quality compliance within US Operations. Support quality deliverables for projects within US Operations. Recommend and implement process improvements within the US Operations.
Major Areas of Accountability:
- Provide quality engineering support to US Operations to ensure FDA/ISO compliance and act as first line support for quality issues.
- Recommend and implement quality improvements of product and processes to ensure regulatory compliance and promote continuous improvement.
- Conduct and document root cause investigations of non-conforming processes and products.
- Participate in and/or facilitate Material Review Board meetings.
- Participate in and/or lead product and process risk management activities.
- Participate in or lead Corrective and Preventive Actions as appropriate.
- Review sampling techniques/methods/rationale and test methods to ensure appropriateness.
- Review quality content in change control for products and processes.
- Review and author validation documents and validate processes.
- Initiate Change Requests to update documentation and processes.
- Maintain QMS documents.
- Perform data analysis; write summary reports and other technical memoranda.
- Support Supplier Quality activities as assigned.
- Other duties as assigned.
- Bachelor's degree from a four-year College or University in a relevant science or engineering discipline.
- Minimum three years related experience and/or training in medical device manufacturing.
- Experience in medical device process and product validation, sampling, sample size determination, DOE, process analysis/capability, hypothesis testing, analysis of variance, and repeatability and reproducibility.
- Occasional travel, both domestic and international.
- Experience working with technical documentation.
Required Knowledge, Skills and Abilities:
- Knowledge of FDA regulations and ISO standards (i.e. 13485, 10012).
- Knowledge of statistical methods and sampling plan determination.
- Knowledge of Failure Mode and Effect Analysis process.
- Effective verbal and written communication skills.
- Effective organizational skills, which includes time management regarding tasks.
- Excellent data analysis skills and proficiency using Statistical tools (Minitab) in problem solving.
- Analytical problem solving skills.
- Effective computer skills including knowledge of Microsoft Office.
- Ability to effectively manage multiple projects and priorities.
- Ability to successfully work within a team based environment.
- Ability to understand customer needs and requirements.
- Attention to detail.
- Certified Quality Engineer (CQE) through ASQ
- Experience with continuous improvement, Lean, six-sigma, or similar programs and techniques
- Experience in reliability engineering
- Familiarity with geometric dimensioning and tolerances
- Lead auditor for both suppliers and internal audits.
The majority of time is spent in an office environment that requires the frequent use of a computer (including typing on a keyboard). While performing the duties of this job, the employee will occasionally be required to go onto the production floor or warehouse area where the employee may be exposed to moving mechanical parts, dust, and chemicals which are monitored and within acceptable OSHA levels. Entering clean room areas will require the removal of makeup and jewelry and the donning of clean room apparel. The noise level in the work environment is usually quiet to moderate. Light travel within the US performing quality audits at suppliers. Occasional overseas travel.