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Quality Control Inspector I
2 months ago
B. Braun Medical, Inc. is a renowned entity in the healthcare sector, dedicated to enhancing patient care through innovative solutions. As part of a legacy spanning over 180 years, we focus on providing advanced technologies for surgical procedures and related services.
Position Summary:
The QC Inspector I plays a crucial role in ensuring the quality and compliance of medical devices. This position is responsible for conducting inspections and maintaining accurate documentation in accordance with regulatory standards and company policies.
Key Responsibilities:
1. Execute inspection tasks as directed by the Quality Control Supervisor, prioritizing daily activities effectively.
2. Perform independent inspections of medical devices following established standard operating procedures (SOPs) and product specifications.
3. Ensure compliance with all relevant SOPs and Work Instructions, documenting activities as required.
4. Utilize SAP for recording inspection activities, generating inventory reports, and managing complaints and returns.
5. Participate in special projects as assigned.
6. Inspect packaging, labeling, and assembly operations in-house, adhering to established SOPs and specifications.
7. Regularly inspect and process returns, complaints, and related documentation.
8. Adhere to applicable ISO and FDA regulations as outlined in the Quality Manual.
9. Collaborate with other departments to facilitate the receiving and shipping processes.
10. Present job tasks effectively to internal and external auditors.
11. Maintain proper records management, both physically and electronically.
Qualifications:
Required:
- Associate Degree in a relevant field or equivalent experience.
- Minimum of 2 years of experience in Quality Control, preferably in surgical instruments.
- Understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Proficient PC skills and familiarity with SAP.
- Ability to operate general inspection equipment such as micrometers, calipers, and scales.
- Capability to interpret technical drawings and specifications.
- Knowledge of sampling plans, such as Acceptable Quality Level (AQL).
Desired Skills:
- Strong communication skills, both written and verbal.
- Mathematical proficiency for calculations involving rates, ratios, and percentages.
- Ability to apply logical reasoning to address various situations.
Physical Demands:
This role may require lifting and moving items up to 50 pounds. The work environment may involve handling instruments that could be contaminated, necessitating adherence to safety regulations.
What We Offer:
B. Braun provides a comprehensive benefits package, including healthcare, a 401(k) plan, and tuition reimbursement. We are committed to continuous improvement and excellence in healthcare products and services.
