JOB SUMMARY

The Sr. Engineer, Quality Design & Development position is primarily responsible for Design Control (product development), Regulatory compliance, qualitative and quantitative data analysis, complaint investigation and analysis, Manufacturing support, Training, Metrology and Gage R&R, and other Quality functions. Additionally, this role is expected to provide input and contribute on Quality System strategies and approach.

ESSENTIAL RESPONSIBILITIES

• Develop and perform operational and process qualifications for customer manufacturing processes in conjunction with other engineering departments.
• Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.
• Initiate the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments per project requirements.
• Generate the Quality Plan for development projects.
• Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection.
• Create appropriate sampling plans along with identifying inspection and acceptance criteria.
• Review and/or document Design Control activities for Project Phase Reviews and Product Verification testing as required per project requirements.
• Perform vendor audits and qualifications.
• Represent quality engineering in phase reviews and other aspects throughout product development.
• Manage the internal audit system schedule and perform the duties of a Lead Auditor including training internal auditors.
• Perform internal audits to assess compliance to FDA and ISO 13485 requirements, as well as the internal Quality System, including investigation observations and findings and reporting.
• Member of customer and 3^rd party quality audit team. May be required to lead this effort.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, including CAPA’s, CCR’s and NMR’s.
• Provide trending analysis on CAPA, NMR and other quality metrics.
• Provide quality oversight on maintaining ISO Class 7 clean rooms including review and trending of the testing and monitoring reports
• Reliable, consistent, and punctual attendance is an essential function of the job
• 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

• A Bachelor’s degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Extensive experience with medical device QSRs in design control and production environments.

• Strong familiarity with Class II or Class III medical devices requirements
• Knowledge of FDA/cGMP and MDD regulations/guidelines.
• Experienced with ISO13485
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must possess excellent verbal communication, organizational, and management skills.
• PREFERRED REQUIREMENT: CQE certification

• Strong verbal and written communication skills including technical report writing
• Ability to work with a wide variety of functional areas including R&D, Manufacturing, and QA, accomplishing results with minimal guidance.
• Must be able to read, write, and speak fluent English
• Demonstrated use of Quality tools/methodologies including Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, and Gauge R&R.

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

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.