Assembler 2
On-siteConcord, North Carolina, United States
Job Summary
Perform assembly, packaging, and labeling of surgical and vascular medical devices while operating certified manufacturing processes. Execute production activities using batch records and SOPs, conducting in-process and final visual inspections to ensure compliance with GMP, FDA, and ISO standards. Monitor downtime and scrap metrics, coordinate batch schedules, and handle non-conforming materials per established procedures. Maintain cleanroom standards, troubleshoot production issues, and provide guidance to associates on safety and continuous improvement initiatives. Work in a cleanroom environment with required PPE, meeting daily targets aligned with the production plan.
Required Qualifications
- High School Diploma/GED
- 1 to 3 years of experience in a high paced medical manufacturing environment
- Knowledge of EH&S standards and safety procedures
- Strong understanding of manufacturing processes and production flow
- Knowledge of GMP and Quality Systems
- Familiarity with GDP
- Ability to interpret and apply manufacturing documentation (e.g., SOPs, batch records, specifications)
- Ability to perform inspections and testing activities (visual, in-process, and final product verification)
- Intermediate troubleshooting and problem-solving skills related to equipment, processes, and set-up conditions
- Basic understanding of equipment maintenance principles
- Awareness of escalation processes for quality, safety, or production issues
- Basic mathematical skills (addition, subtraction, multiplication, division, fractions, decimals, and percentages)
- Basic computer skills, including proficiency in a Windows environment and Microsoft Office (Outlook, Word, Excel)
- Ability to operate multiple manufacturing processes across different areas based on certification level
- Ability to ensure material readiness and proper flow within assigned processes
- Understanding of non-conforming material handling and disposition processes
- Ability to support and guide other associates in process execution as needed (operations trainer support)
- Knowledge of Lean principles and 5S; ability to apply them in the workplace
- Basic understanding of continuous improvement concepts
- Minimum of 4 days of in-office presence per week
- Proof that you are fully vaccinated against COVID-19
Desired Qualifications
- Familiarity with GDP
- Effective oral and written communication skills
- Bilingual Spanish/English
- Ability to work independently and within cross-functional teams
- Ability to train, guide, and support other associates in daily operations
- Demonstrates technical knowledge as a subject matter resource within assigned operations
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