Overview
Deviation Writer Jobs in Fishers, IN at INCOG BioPharma Services
Essential Duties:
Review and interpret technical drawings, work instructions and other quality checks.
Communicate with customers regarding drawings, exceptions and deviations.
Participate in the development and implementation of quality control procedures, work instructions and training materials.
Conduct training sessions with applicable personnel.
Develop gaging methodology.
Perform contract review.
Assists in customer, internal and regulatory audits.
Collaborate with operations to create manufacturing inspection plans and frequencies based on tool life and tool paths.
Investigate nonconforming product, create and disposition NCMR’s
Stay updated with industry trends, regulatory changes, and best practices in medical device quality and manufacturing.
Assist in customer complaints and resolution.
Implement 5S methodologies throughout the manufacturing processes.
Create deviations for customer approval.
Release product for distribution.
Conducts regular inspections of products, materials, and processes on the floor to ensure compliance to Quality and Customer Requirements.
Perform visual inspections, measurements, and tests to identify any defects, deviations, or non-conformities.
Perform First Article Inspections.
Performs final inspection to ensure product meet customer requirements and expectations.
Document all inspections and tests performed.
Maintain accurate records of all inspections and tests performed and other quality documentation.
Participate in root cause analysis and problem-solving activities to identify and resolve quality issues.
Discuss errors directly with machinist/operators so corrections can be made when required.
Trains machinist on proper inspection methodology.
Ensures all coworkers strictly follows SOPs, GDPs and cGMPs.
Maintain accurate staging queues.
Assist in meeting deadlines and schedules to ensure customer OTD metrics.
Required Experience:
High school diploma or GED
Previous experience in inspection.
Required Skills:
Technical writing skills.
Strong Knowledge of ISO 13485:2016 and 21 CFR part 820.
Read and analyze blueprints.
Strong understanding of GD&T
Ability to work independently and prioritize tasks in a fast-paced environment.
Strong problem-solving skills.
Strong knowledge of inspection methods.
Strong Communication Skills
Physical Requirements:
Sitting at a desk for prolonged periods of time
Standing for prolonged periods of time
Able to lift/carry up to 50 lbs.
Job Type: Full-time
Pay: $22.90 – $24.34 per hour
Expected hours: 40 per week
Benefits:
401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Shift availability:
Day Shift (Required)
Ability to Commute:
Shelton, CT 06484 (Required)
Ability to Relocate:
Shelton, CT 06484: Relocate before starting work (Required)
Work Location: In person
Title: Deviation Writer
Company: INCOG BioPharma Services
Location: Fishers, IN
