Sr. Quality Assurance Engineer

Company : Minerva Surgical

Country: United States

Location : Santa Clara, California

Post: Tue, 30 May 2023 08:39:55 GMT

Expires: Tue, 27 Jun 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

POSITION SUMMARY:

Responsible for supporting the development, implementation, and maintenance of quality systems to ensure compliance with EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.

 

DUTIES & RESPONSIBILITIES:

Corrective & Preventive Action (CAPA)/ Supplier Corrective Action (SCAR) System:

Help facilitate CAPA/SCAR System

Manage CAPA/SCAR/Correction Log

Ensure assigned internal and supplier corrective and preventive actions (CAPA/SCAR) are documented and conducted in a proper and timely manner, including verifying implemented are effective

Conduct or support problem solving, root cause investigation, developing action plans, effectiveness checks activities

Review CAPAs/SCARs/Corrections at different stages to ensure appropriate and complete

Quality Audits:

Help facilitate audits, internal and external

Issue CAPAs/Corrections resulting from internal and external audits

Supplier Quality Assurance:

Support supplier evaluation & monitoring activities

Help coordinate supplier audits during initial qualification and re-evaluation, review the reports, follow-up issuing SCARs and ensuring SCARs are completed.

R&D Quality Assurance:

Collaborate with R&D project teams to support and or process design and development activities.

Provide comprehensive review of the Risk Management File, Design History File, Device Master Record and all other deliverables required for each phase per the Design Control system.

Product Complaint Handling

Help facilitate Complaint/MDR System

Manage Complaint Log

Ensure complaint management activities are conducted in a proper and timely manner, including receipt from the field, investigation receipt and closure 

Work collaboratively with other departments (e.g. R&D, Operations, etc.) on complaint event analyses

Conduct or support problem solving and root cause investigation

Review complaints at different stages to ensure appropriate and complete

Returned Goods Analysis (RGA)

Help facilitate RGA System

Review RGAs for potential complaints

Inspect returned product for stock acceptability

Review/close RGAs

Nonconforming Material Reports (NCRs) /Deviations

Help facilitate NCR and Deviation Systems

Initiate NCRs and Deviations, as necessary

Review NCRs and Deviations for general compliance and completeness

Review and close NCRs and Deviations

Engineering Change Orders (ECOs)

Initiate ECOs, as necessary

Review ECOs to ensure correct and complete and to detect any compliance issues

Quality Assurance:

Act as backup for Device History Review and release of Finished Product

Act as backup for coordinating servicing, preventive maintenance, and calibration of equipment.

Act as backup for Data/Trend Analysis

Other duties as required to support operation of the quality system.

 

PREFERRED QUALIFICATIONS:

Preferred Requirements:

Knowledge of CAPA/SCAR system.

Knowledge of trending and analysis of Quality Data.

Coordinate or conduct Supplier Audits.

Understands basic statistical data analysis.

Proficiency with MS Word, MS Excel, and MS Visio.

High level of attention to detail and organization.

Proven ability to effectively work cross-functionally at all levels of the organization.

Must be able to function in a typical startup environment (fast pace, multi-tasking, tight deadlines).

Excellent verbal, written, and presentation communication skills.

Understanding of Medical Device Risk management.

Working knowledge of current EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.

 

Preferred Education and/or Job experience:

Bachelor’s degree in Engineering or related technical discipline

5+ years’ experience in a quality role in the medical device industry, preferably with Class II and/or Class III medical devices.

Understanding of design controls, risk management, statistical techniques, complaints/MDRs, NCRs/MRB, Deviations, RGAs, CAPAs/SCARs, internal audits, and supplier audits.

Preferred Certifications: ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ASQ Certified Biomedical Auditor (CBA).

 

Powered by JazzHR