Maintenance/Facilities Technician

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Job description

Pay: $50.00-$63.50/hr - Paid Weekly

M-F 8am to 5pm

On-site in Campbell, CA 95008

4 months+ assignment

Top 3 responsibilities and a "day in the life thereof":

1. Initiation, authoring/Investigating and closure of Non-conformances.

2. Equipment support-Review of IQ/OQ/PQ, Product support as needed.

3. Endotoxin/Bioburden Investigations.

Day in the life thereof: Willingness to support the team where needed, getting the job done within the timelines.

Personality traits / Organizational Culture fit: Attitude to learn and support the team, fast paced culture to support manufacturing/production, attention to detail.

Interview process after initial resume/bio submittal: Video screening followed by on-site interview with Quality Management and Senior Quality Staff members.

EDUCATION/EXPERIENCE:

BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience

Experience working with catheters, endovascular or neurological devices highly desired

Experience addressing supplier or process issues (CAPAs, NCMR/NCRs, SCARs, etc.)

Experience in Endotoxin investigations, Bioburden and Environmental program is desired

Must be knowledgeable about quality system requirements (FDA 21 CFR Part 820, ISO 13485 or ISO 9001), risk management standards (ISO 14971) and good manufacturing practices

Excellent communications skills (both written and verbal)

Must be able to provide thorough and meticulous review of documents

Must be able to write clear, concise, and well thought out technical documentation with a focus on failure investigations and inspection procedures

Must be able to perform multiple tasks concurrently with accuracy

Proficiency with Microsoft Office products

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:

Responsible for Quality input to define required validations necessary to support significant process changes on commercially launched products.

Support the non-conforming materials program, including authoring and leading investigations.

Collaborate with team members to define validation requirements, specifications, testing, and component/product acceptance activities, author and route validation protocols and reports.

Analyze data by completing hypothesis, normal distribution, and process capability analysis tests intended to provide input on the quality of the product/process being evaluated/monitored.

Create and revise quality assurance procedures as required to maintain compliance to changing regulations and guidance documents.

Lead training on the use of procedures to promote compliance with Quality System and Regulations to a broad audience.

Liaison with laboratories to conduct routine product testing or root cause analysis related to testing failures or deviations.

Conduct methodical root cause investigations and provide guidance on actions necessary to prevent recurrence.

Direct interaction with suppliers to qualify and maintain approved supplier status. May be required to evaluate supplier notification of change and recommend necessary actions to maintain compliance.

Perform statistical analysis of manufacturing data and quality processes and creation of reports based on quality documentation

Review DCO's involving product or process changes to ensure consistency with company procedures and quality system compliance.

Conduct and review Risk Management assessments on product and process changes.

Conduct failure mode effect analysis on product

Support projects (including product enhancements) in an aggressive manner consistent with corporate objectives.

Benefits (employee contribution):

Health insurance

Health savings account

Dental insurance

Vision insurance

Flexible spending accounts

Life insurance

Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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