What are the responsibilities and job description for the Quality Assurance Support Specialist position at Sim Surgical?
Job Summary: The QA Support Specialist supports the Quality Assurance team by assisting in the investigation, documentation, and resolution of quality-related issues, including CAPAs, customer complaints, supplier quality, and calibration. This role ensures compliance with internal and external quality standards and contributes to continuous improvement efforts.
Principal Duties and Responsibilities (under the direction of the Lead QE):
Qualifications & Skills:
REQUIRED:
PREFERRED:
Travel
Great Benefits!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.
Principal Duties and Responsibilities (under the direction of the Lead QE):
- Corrective and Preventive Actions (CAPAs) Support:
- Assist with gathering and analyzing information to support CAPAs.
- Conduct investigations to determine containment actions for nonconforming conditions.
- Perform root cause analysis using tools such as 5 Whys, Fishbone Diagrams, 8D, or FMEA.
- Assist in defining corrective and preventive actions to mitigate and prevent recurrence of nonconforming conditions.
- Support effectiveness checks by analyzing post-implementation data and trends to verify CAPA success.
- Customer Complaint Assistance:
- Support the response process for customer complaints, ensuring timely investigation and resolution.
- Request and analyze returned parts from customers to confirm the reported nonconforming condition.
- Assist in containment, root cause determination, corrective action, and preventive action efforts related to customer complaints.
- Track and assess corrective action effectiveness to ensure continued compliance and customer satisfaction.
- Supplier Management Assistance:
- Assist in supplier evaluations by requesting supplier quality documentation (e.g., ISO certificates, quality manuals).
- Calibration Management:
- Oversee calibration activities.
- Ensure calibration records are maintained and up to date.
- Coordinate with external calibration service providers and internal teams to schedule calibrations.
- Support troubleshooting efforts for out-of-tolerance instruments.
Qualifications & Skills:
REQUIRED:
- Basic understanding of quality management systems (QMS), including CAPA, customer complaints, and supplier quality management.
- Proficient in using Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
- Knowledge of calibration processes and managing calibration records is a plus.
- Strong analytical skills with the ability to gather, interpret, and synthesize data.
- Ability to perform root cause analysis and propose corrective and preventive actions.
- Detail-oriented and capable of managing multiple tasks in a fast-paced environment.
- Strong written and verbal communication skills to effectively interact with internal teams, suppliers, and customers.
- Ability to clearly document quality-related issues, actions, and outcomes.
- Ability to maintain accurate and thorough documentation in accordance with regulatory and company requirements.
- Understanding of industry standards (e.g., ISO 13485, FDA regulations, etc.) and ability to ensure compliance with both internal and external quality standards.
- Experience with audits or supporting audits is a plus.
- Ability to work effectively as part of a team and take direction from the Lead Quality Engineer.
- Willingness to learn new tools and methods to improve processes and drive continuous improvement.
- Able to read and interpret prints
- Familiar with standard measurement tools: micrometers, calipers, comparators, thread plugs, and plug gages
- Must be detail oriented in documentation as well as with measuring techniques
- Must have high visual acuity
- Must be able to perform job functions despite distractions
- Driven to be efficient
- Dedication to performing the jobs in a high paced environment
- Self-motivated; able to work with minimal supervision
- Ability to read and understand standard operating procedures, specifications and forms
PREFERRED:
- Associate’s degree in a related field (e.g., Quality Assurance, Engineering, Manufacturing, etc.) or equivalent work experience.
- Minimum of 1-3 years of experience in quality assurance, quality control, or a related role, preferably in a manufacturing or regulated environment.
- Familiarity with quality tools & techniques such as Root Cause Analysis, 5 Whys, Fishbone Diagrams, FMEA, 8D, etc.
Travel
- No travel is expected for this position.
Great Benefits!
- State-of-the-art facility that is well lit, clean, and climate controlled.
- Benefit Eligibility is immediate, enroll on day one of employment.
- Robust 401k plan with up to 4% employer match after 90 days (immediate 100% vesting).
- 9 Paid Holidays and 120 Hours (pro-rated) Paid Time Off First Year.
- Health / Dental / Vision Insurance
- Company Paid Basic Life / AD&D
- Voluntary Short / Long-Term Disability Insurance
- Professional development assistance
- Tuition reimbursement, and more!
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.
