Quality System SpecialistWe are searching for an experienced Quality System Specialist at our Anaheim facility. Are you detail-oriented, organized, and passionate about quality assurance? Join Oliver Healthcare Packaging, where innovation and commitment to excellence meet to create a safer, healthier world. We are seeking a dedicated
Quality Systems Specialistto ensure our internal processes run smoothly and efficiently while maintaining the highest standards of quality.
Position SummaryAs the Quality Systems Specialist, you will oversee key systems including Document Control, Record Retention, Internal Audits, Temporary Deviation, and Control of Standards. In addition to supporting CA-PA functions, handling customer complaints, audits, and managing non-conforming materials, you will also serve as the ISO Deputy Management Representative. If you're ready to be at the heart of our quality assurance team, this role is for you!
Primary Responsibilities: - Audit Oversight: Develop the annual internal audit schedule, participate in audits, and assist teams in corrective action resolutions.
- Document Control: Manage and maintain the document control system, ensuring compliance with regulations through training and updating procedures.
- Standard Maintenance: Oversee the list of current standards, ensuring up-to-date versions are readily available.
- QIR Management: Issue, monitor, and evaluate Quality Improvement Requests (QIRs) and CAPA actions for closure.
- Customer Audits: Prepare for and conduct customer audits, respond to reports, and assist in corrective actions.
- Training Coordination: Manage training systems by logging completed training and opening new requirements.
- Quality Reporting: Generate quality reports, charts, and graphs to keep management informed of any quality-related issues.
- Non-conforming Material: Make independent decisions on final disposition of non-conforming products.
Secondary Responsibilities: - Support CA-PA functions, including customer complaint investigations and writing audit responses.
- Oversee the Record Retention System to ensure compliance with SOPs.
- Assist in the revision and writing of SOPs as needed.
Qualifications:Basic Qualifications - Education: High school diploma or GED.
- Experience: 2+ years of training/experience in a quality-related role.
- Skills: Familiarity with quality system standards (e.g., ISO 9001, 13485, QS9000).
Preferred Qualifications - Education/Experience: Bachelor's degree in Business Management or Quality, and 3+ years in a quality-related role.
- Interpersonal Skills: Strong analytical, verbal, and written communication skills. Experience presenting information to diverse groups.
- Technical Skills: Proficiency with MS Office, ERP systems, and advanced mathematical concepts. Familiarity with ISO 13485 is a plus.
- Problem-Solving: Ability to define problems, collect data, establish facts, draw conclusions, and make independent decisions.
Why Join Us?- Competitive Pay: Earn a highly competitive wage. $41,000-$65,000/Annually
- Comprehensive Benefits Package: Health, dental, vision insurance, 401(k) with company match, paid time off, and more.
- Growth Opportunities: Access to ongoing training and professional development programs.
- Positive Work Environment: Be a part of a supportive, safety-focused, and diverse team that values every employee.
- Impactful Work: Contribute to a company whose mission is to create packaging solutions that protect people and save lives.
Apply today to start making a difference in healthcare packaging with Oliver!