Principal Quality Engineer BARRX Medical

Company Information
Company:BARRX Medical
Website:www.barrx.com
Job Description

Major Duties and Responsibilities:



The work of the Quality Engineer varies based on the organization needs but is likely to include some or all of the following activities:



Proactively investigate, identify, and implement best-in-class Quality Engineering practices.

Identify and implement effective process control systems to support the development and qualification of new and on-going manufacturing of products to meet or exceed internal and external requirements.

Establish effective corrective action plans for internal and supplier non-conformances. Drive towards timely closure and effectiveness.

Participate as resource in validations applicable to processes and product.



Manage the non-conformance reporting system, driving timely disposition and closure. Lead and participate in MRB meetings (Purchased materials and in-house manufactured product). Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems.



Perform internal and vendor Q.A. facility audits and administer any resultant corrective action notices.



Provide support to audits (FDA, DGM, UL, international representatives) and ensure the execution of corrective action and compliance with internal quality procedures and external standards.



Utilize standard and advance statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities, and develop statistically sound tolerance limits.



Develop, refine and document QA test and inspection procedures. Select, order, and qualify inspection equipment as required.



Provide technical guidance and training in statistical analysis techniques, experimental design and other QA Engineering areas of expertise.



Review drawings for inspection points. Recommend inspection points based on FMECA criticality analyses.



Create/update Inspection forms with inspection criteria and sampling plan



Track and maintain calibration and preventive maintenance status. Coordinate in-house and off-site calibrations with certified calibration house.



Write protocols and perform validations/verifications as necessary.



At times may be asked to assist with IQC inspections or other special inspections during peak demand periods.



Write/review FMECAs/Risk Management.



Write/revise QSP or other department operating procedures (QSP revamp project support).



Work with Manufacturing Engineering to address supplier issues.



Calculate supplier yield on a monthly and quarterly basis. Develop pareto charts in order to categorize failures.



Review sterility report bi-monthly for process compliance against cycle agreement.



Coordinate and review results of Quarterly CER Environmental Monitoring.



Assist in complaint analysis as needed.



Perform training pertaining to quality.



Will provide management to direct reports



Education Requirements:




BS in Engineering or related field



Experience Requirements:




Minimum 7 years of related experience in Medical Device or other regulated healthcare industry.



Demonstrated use of Quality tools/methodologies.



Ability to apply statistics



Risk Management experience



Ability to interpret engineering drawings



Disposable devices and electronics background



Working knowledge of 21CFR Part 820

and ISO13485:2003 or ISO9001 and EN46001.







Other Qualifications:



Strong written and oral communication skills.

Strong computer skills with specific experience with Microsoft Word, Excel, Project, Adobe Acrobat, QAD or equivalent.

Strong data management skills.

Ability to establish and maintain good working relationships with all personnel, and management team.

Location:	540 Oakmead Parkway Sunnyvale, CA 94085 United States