Quality Assurance Engineer
Cincinnati Sub-Zero Products, Inc., a leading manufacturer of Patient Temperature Management devices, is in need of a Quality Engineer to join our team.
Essential Duties and Responsibilities include the following:
Other duties may be assigned as deemed necessary by the supervising manager to support established Medical Division goals and corporate policies.
- Support Quality Systems Manager and Director of Medical Quality & Regulatory Compliance as required.
- Assist sustaining and development engineering with product development quality assurance activities in support of FDA regulatory requirements.
- Evaluate engineering reports and development procedures to verify that systems function seamlessly according to user requirements and conform to established guidelines.
- Represent Quality Assurance and Regulatory Compliance by providing technical accuracy reviews of process and product validations and product risk assessment.
- Participate in design reviews to provide input on functional requirements, product designs, schedules, impediments, software usability or potential problems.
- Plan and coordinate inspection/test strategies with development team, and project owners and stakeholders.
- Play an active role on improvement initiatives. Perform data and trending metrics analysis to facilitate increased quality, productivity and efficiency.
- Assumes tasks/projects as needed for overall success of an integrated product team and steps out of the job responsibilities when necessary to benefit the team and company.
- Serve as a Quality Representative on the Material and Supplier Review Board.
- Conduct internal quality system and/or external supplier audits as assigned.
- Facilitate and support root-cause analysis and the expediting of closure activities related to CAPA/SCAR/NCM processes.
- Support complaint coordinator in investigating quality issues related to CSZ processes and/or supplied product.
- Guide manufacturing, inspection and testing to ensure QSR and Quality System compliance over materials, facilities and product.
- Create, revise, and review quality system documentation related to job activities.
- Plan and implement training activities as needed.
Work Experience/ Competency Requirements:
CQA and CQE desired. Proven experience successfully diagnosing, reporting, tracking and resolving quality issues.
Excellent understanding of engineering development and validation processes; ability to easily adjust and apply this knowledge in a dynamic product development environment. Proven ability to interpret engineering drawings and document operational processes then translate into clear and concise quality assurance testing/inspection requirements.
Well versed in ISO and FDA standards, procedures and regulations with emphasis on ISO13485, ISO9001, ISO14971, ISO IEC62304 and 21CFR820
Technical Experience Requirements:
Microsoft Office Products including Access reporting. Mini-tab competency desired.
Proven experience in Corrective Action Root Cause Techniques
Keyboard proficiency
5+ years experience in Medical Industry
Talents/ Behavioral Traits Desired in Ideal Candidate:
Advanced Statistical and FMEA knowledge
Self –directed
Familiar with Good Documentation Practices.
Qualified ISO13485 Internal Auditor
Education Requirements:
Bachelor’s degree in Engineering, or equivalent discipline (or equivalent industry experience) with 5-10 years experience minimum.
CSZ offers an excellent benefits package including medical& dental insurance, profit sharing and 401k w/ profit sharing/match.
An Equal Opportunity Employer M/F/D/V
Please send resume with salary history to:
Cincinnati Sub-Zero Products, Inc.
HR Dept.
12011 Mosteller Road
Cincinnati, Ohio 45241-1528
Email:
hr@cszinc.com