Quality Compliance & Document Control SpecialistLocation: Escondido, CA - Onsite
Reports To: Quality Manager
Pay Range: $75-95,000
Position SummaryARCH Medical Solutions is seeking a detail-oriented and proactive
Quality Compliance & Document Control Specialist to support the maintenance, effectiveness, and compliance of our Quality Management System (QMS). This role combines responsibility for document control, training administration, audit readiness, regulatory compliance, quality records management, and continuous improvement initiatives within a precision machining environment serving the medical device industry.
The ideal candidate will have experience with ISO 13485, document control processes, quality systems administration, internal audits, and regulatory compliance. This individual will work closely with cross-functional teams to ensure quality documentation remains accurate, current, and compliant with customer and regulatory requirements.
Essential Duties and ResponsibilitiesQuality Management System (QMS)- Maintain and continuously improve the Quality Management System in accordance with ISO 13485, FDA regulations, customer requirements, and company standards.
- Manage QMS documentation, procedures, forms, policies, and records to ensure current revision status and availability.
- Support external customer audits, surveillance audits, recertification audits, and regulatory inspections.
- Coordinate and support the Internal Audit Program.
- Assist with CAPA, customer complaint investigations, NCMRs, and corrective action activities.
- Perform quality data analysis and trend reporting related to customer complaints, scrap, quality metrics, and process performance.
- Support development and implementation of continuous improvement initiatives.
- Conduct QMS-related training and maintain training compliance records.
- Serve as a resource regarding quality policies, procedures, and regulatory requirements.
Document Control & Records Management- Maintain control of all quality system documentation and related records.
- Ensure procedures, work instructions, SOPs, forms, and engineering documents are properly reviewed, approved, distributed, and archived.
- Manage document revision history and associated document control logs.
- Process Engineering Change Orders (ECOs) and track implementation activities.
- Create and update inspection forms, method sheets, and balloon/bubble drawings.
- Maintain Device History Records (DHRs) and quality records in accordance with customer and regulatory requirements.
- Manage approved supplier documentation and supplier quality agreements.
- Facilitate employee training on new or revised procedures and ensure training records are maintained.
- Provide administrative support including scanning, filing, labeling, printing, and record retention activities.
Compliance & Cross-Functional Support- Assist with contract and customer requirement reviews to ensure compliance.
- Monitor and maintain quality-related KPI data and reporting.
- Collaborate with HR and department leaders to maintain training matrices and onboarding documentation.
- Support ERP system data entry and maintenance related to quality and documentation activities.
- Interface with customers and suppliers regarding quality documentation and compliance matters.
- Participate in root cause investigations and quality improvement projects.
- Perform other duties as assigned.
QualificationsEducation & Experience- Associate degree in a technical, quality, engineering, or related field with 3+ years of relevant experience; or
- Bachelor's degree in Quality, Engineering, Life Sciences, or related discipline preferred; or
Equivalent combination of education and experience.
- Experience in Quality Systems, Document Control, or Regulatory Compliance within a regulated manufacturing environment.
- Experience supporting ISO 13485 quality systems
- Experience with medical device manufacturing preferred.
- Experience with ERP systems, document management systems, and electronic quality records preferred.
Knowledge, Skills & Abilities- Working knowledge of ISO 13485 and FDA Quality System Regulations.
- Strong understanding of document control processes and best practices.
- Experience conducting internal audits and supporting external audits.
- Knowledge of CAPA, complaint handling, root cause analysis, and continuous improvement methodologies.
- Proficiency in Microsoft Word, Excel, Outlook, and document management systems.
- Excellent written communication and technical editing skills.
- Strong organizational skills with exceptional attention to detail.
- Ability to manage multiple priorities and meet deadlines.
- Ability to work independently and collaboratively in a fast-paced manufacturing environment.
Preferred Certifications- ASQ Certified Quality Auditor (CQA)
- ISO 13485 Internal Auditor Certification
Additional Notes ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities.
