Engineer I, Quality

THIS POSITION IS ELIGIBLE FOR A NEW HIRE BONUS OF $5,000.00

JOB SUMMARY

This position is primarily responsible for monitoring and auditing the quality of all manufactured goods in a medical device industry. Will work to not only find defects, but also to find the cause of the defect and develop a solution. Interact with customers and suppliers in support of engineering projects.

ESSENTIAL RESPONSIBILITIES

• Provide Quality Engineering support for engineering project development, or sustained manufacturing.

• Provide Quality Project Management support as needed for product transfers from development to validation.

• Validation System Owner responsible for the development and management of the validation master plan along with the validation determination.

• Develop and maintain Validation Standard Operating Procedures.

• Develop and maintain project Quality Plan for assigned projects.

• Develop protocols, perform statistical analyses, and write reports for validations and formal process development, which requires quality-engineering involvement such as DOEs.

• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.

• Provide Quality Engineering support for manufacturing.

• CAPA (Corrective and Preventative Action) system owner responsible for the support of the corrective action system and procedures.

• Interact with customers and suppliers to resolve CAPA and complaint investigations and in support of manufacturing.

• Provide Quality Support for the disposition of material via NCRs.

• Provide Quality Project Management Support as needed for product transfers from validation to production.

• Vendor approval and maintain and assess vendor performance data (i.e., SCAR/on time).

• Review and document procedure changes for quality requirements and compliance with the quality system.

• Develop quality systems and procedures as needed.

• Audit support for third party audits, customer audits and internal audits.

• Support the implementation of continuous improvement initiatives for production processes.

• Develop and maintain production quality control plans.

• Initiate and maintain SPC (Statistical Process Control) for production processes.

• Provide initiative and support for FMECA (Failure Modes & Effects Criticality Analysis), and DOE (Design of Experiment as applicable.

• Back up to Quality Systems Administrator.

• Complies with company, quality and safety standards, policies, and procedures.

• Other duties as assigned.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• Bachelors degree in engineering discipline with 0 years of experience; or a combination of education and relevant work experience.

• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.

• Must be able to read, write, and speak fluent English.

• Must possess excellent verbal communication, organizational and management skills.

• Training or equivalent experience in computer use and software-Microsoft Word, Excel, Power Point and Access.

• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.