QC Inspector - 2nd shift
Astrix · Lino Lakes, MN · 1 wk ago
Quality AssuranceFull-time
Key Responsibilities
- Perform First Article, In-Process, and Final Inspections of medical device components.
- Conduct visual and dimensional inspections using precision measurement equipment.
- Accurately document inspection results, quality records, travelers, and device history records.
- Analyze inspection data and identify quality trends or nonconformances.
- Support Nonconforming Material Reports (NCRs) and Return Material Authorization (RMA) activities.
- Verify compliance with Good Documentation Practices (GDP) and quality system requirements.
- Assist with ISO 13485 quality system activities and audit readiness.
- Collaborate with manufacturing, engineering, and quality teams on new product development and process improvements.
- Support statistical process control (SPC), sampling plans, root cause investigations, corrective actions, and continuous improvement initiatives.
- Provide training and guidance on quality inspection techniques as needed.
- Interface regularly with ERP systems, JobBOSS software, and Microsoft Office applications.
Required Qualifications
- 5+ years of quality inspection experience within the medical device manufacturing industry.
- Experience working in regulated environments, including GMP and ISO 13485 standards.
- Strong understanding of quality control principles, inspection methodologies, and testing procedures.
- Experience utilizing AQL sampling plans, acceptance sampling, and 100% inspection methods.
- Ability to identify product and material nonconformances through visual and dimensional inspection.
- Proficient in reading and interpreting engineering drawings and GD&T requirements.
- Knowledge of precision manufacturing processes including CNC Swiss, CNC Turning, CNC Milling, and EDM.
- Understanding of both imperial and metric measurement systems.
- Strong mathematical skills involving decimals, fractions, percentages, and measurement conversions.
- Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
Preferred Qualifications
- Experience with SolidWorks and CAD models.
- Knowledge of Statistical Process Control (SPC).
- Previous experience training manufacturing personnel on inspection methods.
- Continuous improvement and problem-solving experience.
Desired Competencies
- Customer-focused with a strong sense of urgency and accountability.
- High level of integrity, professionalism, and ethical conduct.
- Strong communication and teamwork skills.
- Ability to foster a positive work environment and collaborate effectively across departments.
- Self-motivated, detail-oriented, and committed to delivering high-quality results.
Pay
Salary: $57k-70k/yr. (depending on experience)
Schedule
2nd shift M thru Thr. - 3:30pm - 1:30am