Document Control

Job Title: Document Control

Job Description: The Document Control position is responsible for Control of Documents and Records activities involved in QA and Manufacturing Operations, as well as Receiving Inspection (Certs Review/Batch Control & Labeling), special Product and Material Testing, and Quality Data Mining/Reporting

Responsibilities:

Quality Records filing (MDR/PHR, DHR/LHR) for Medical Devices plus Training records

• Maintaining the MD Files/Part History Records current (up-to-date document revisions)
• Compiling Training Records by Employee (Hardcopies by Status and Scans,
• Maintaining Employee Training Records List)
• Conduct/Follow Up required training for document changes as well as training forGMPs, GDPs, and Product Awareness

Review and Scanning of Quality Records

• Thorough Review of LHR Lot History Records (Packing Slip/Invoice, Work Order, Certs) prior to Scanning, then Scanning/Collating/Electronic Filing of each record

Perform Receiving Inspection of Critical Materials (rubber materials, inserts, other)

• Thorough Review of item identification, traceability information, certificates of Analysis
• Data Entry in Material Batch Log of ERP system, issuance of Green Batch Labels for each material/insert container, Placement of Batch Labels to each material/insert container

Maintaining/upkeep of Quality Data/Information in ERP/RDS Quality module for CCF, RGA, NCR and CAPA

• Entering Red Tag NCRs
• Follow Up on pending matters in CCF, RGA, NCR and CAPA modules
• Data Mining of Quality information for regular reporting /tracking such as

Performance metrics, Quality metrics and other data analysis

• Maintaining monthly issuance of KPIs Performance Metrics and posting them in the KPI Metrics Board

Leads the ECO (Engineering Change Order) Process for:

• New and revised part drawings and specifications (external documents)
• New and revised QMS (internal) documents such as Quality Manual, SOPs (standard operating procedures), WIs (work instructions), and Forms
• Upkeep of relevant applicable industry standards (regulatory)
• Maintaining accurate Router Information and Changes to Router instructions
• Seeks ECO approvals to release document
• Issuance/Maintenance of current revs and removal of obsolete documents, both hardcopies and electronic copies

Assist in maintaining ISO certifications of Critical Suppliers using ISO Cert Tracker and upkeep of quality surveys

Maintain scorecards from Customers to electronic files

Assist in other QA activities when warranted such as product sampling, product inspection, data reporting, special product functional testing and Materials Testing

Perform other duties as assigned

Qualifications

• Minimum of 2-5 years of hands on experience in a manufacturing environment preferably in the medical component or device industry
• Minimum of high school education, some technical certificates/studies preferred
• Demonstrated experience with inspection and measurement concepts, methods, techniques and quality documentation
• Ability to communicate effectively, both written and verbal, among staff and management
• Hands-on leadership skills with strong organizational, planning, and team building background
• High standards of personal and professional integrity
• Ability to be independent in performing assigned tasks and duties / Self-driven / Multi- tasking
• Has a sense of urgency / figuring it out when necessary
• Proficiency with MS Office programs especially reporting using MS Word and Powerpoint, and data analysis using MS Excel
• Proficiency in written and oral Spanish is preferred

Job Type: Full-time

Pay: $19.00 - $21.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• San Clemente, CA 92673: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Microsoft Office: 1 year (Preferred)

Work Location: In person

Salary : $19 - $21