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Ensure Steri-Tek complies with all applicable regulatory standards including ISO 13485 and 11137, and that all Quality System Procedures are followed in an accurate manner. Assist the Quality Manager in any activities required to maintain the effectiveness of the Steri-Tek Quality System. Below are the primary responsibilities for this position. Additional responsibilities such as project management will be also assigned at the discretion of the Quality Manager, Director of Operations, and/or CEO.
Core responsibility- Maintain Quality Management System (QMS) by proposing and overseeing process changes for constant improvements.
- Review Job Records for accuracy and completeness and confirm processed product has been completed per specifications as described in the Standard Operating Procedures
- Complete any task assigned by the Quality Manager
- Maintain clean and organized work area
- GDP corrections and document archiving
- Contact customers as required to resolve any discrepancies.
- Complete continuing education requirements described during performance review.
- Complete and ensure proper execution of the Steri-Tek Quality Manual
- Ensure that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002.
- Responsible for Non-Conformance initiation, investigation, and execution
- Complete CAPA Management
- Participate in QA Planning
- Serve with Project Management
- Complete Risk Evaluations
- Propose Process Changes
- Review Software implementation
- Review Validation Reports
- Complete Registration/Certifications
- Provide future facility support
Document Control
Ensure all SOPs, forms, labels and other quality related documents are current and accurate. Initiate or review changes to controlled documents following document control SOPs and WIs.
- Follow WI - Document Control when processing requests for the creation of new documents or changes to current documents
- Ensure all submitted Document Change Orders are complete and accurate
- Acquire approval from specific departments according to Document Control Work Instruction
- Acquire customer approval when needed
- Complete new documentation implementation and distribution
- Maintain all records associated with Document Control both electronic and hard copy
Training
Assist the Quality Manager in ensuring all employees are trained to levels necessary to align to SOPs and maintain required certifications.
- Maintain a current training plan for all employees in the Steri-Tek electronic quality management system (eQMS)
- Ensure all employees complete their training via the Steri-Tek eQMS
- Document all completed employee training and certifications
QMS MAINTENANCE
Assist the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs.
- Send notifications or schedule appropriate activities for QMS programs
- Perform investigations, execute corrections
- Schedule and/or perform calibrations for equipment
- Schedule and/or perform preventive maintenance for equipment
- Manage due dates and implementation dates for QMS programs
- Collect and/or create any documentation required for QMS programs
- Perform change order process, non-conforming material process, investigations and closure
- Participate in preparation of audits by potential partners, customer and regulatory agencies
Other duties as assigned.
Requirements
MINIMUM REQUIREMENTS/QUALIFICATIONS
- Medical Device industry experience 2-4 years
- Bachelors Degree in Life Science or related field or equivalent experience
- Medical Device Quality System experience 2-4 years
- Proficient in English language (written and spoken)
- Microsoft Office
- Interpersonal skills and result-oriented
PREFERRED QUALIFICATIONS
- Medical Device industry experience 3-5 years
- Bachelors Degree in Life Science or related field or Medical Device Quality System experience 2-4 years
- Management Experience 1-3 years
Benefits
This is a part-time position. Steri-Tek paid holiday and paid time off on a pro-rated basis for part-time employees.
Compensation: $50.00 - $61.00 per hour
Work schedule: Monday - Friday, 9:00am - 2:00pm
Steri-Tek follows equitable hiring practices. Flexibility in our hiring process allows hiring of talent at levels different from what are posted. The compensation range outlined is based on a target budgeted base salary. Individual base pay depends on various factors such as relevant experience and skill, Interview assessments and responsibility of role, job duties/requirements. Offers are determined using our equitable hiring practices. Steri-Tek offers additional compensation in the form of benefits premiums, 401k matching, and On Target Earning commissions for appropriate positions. Base pay ranges are reviewed each year. We are committed to the principle of pay equity paying employees equitably for similar work.
Steri-Tek
