Quality Engineer II
Fort Lauderdale, FL Posted: 5/7/2021
Role: Engineer II, Quality Ops
Location: Fort. Lauderdale, Florida
We are looking to hire an Engineer to support our client’s (Medical Device Organization) need for support the quality operations of receiving inspection, in-process and finished product while maintaining processes and methods in compliance with the client’s standards.
Duties & Responsibilities:
- Participates in the nonconformance process to ensure timely completion of documentation stage.
- Identifies, Reports and Monitors Nonconforming events for the areas of responsibility.
- Performs product or process failure investigations and implements corrective and preventive actions to prevent reoccurrence.
- Interacts with cross-functional teams to resolve quality issues.
- Quality control, product release authorizations, and quarantine of all suspect or discrepant product.
- Develops Quality Instructions and Quality Standards.
- Support in the development, validation, and implementation of Test Methods.
- Suggests, implements, reviews, and approves engineering changes to support product life cycle.
- Provides adequate QA support to the assigned areas and responds to Internal Audits, and takes actions as appropriate based on CAPAs, Complaint investigations, Nonconforming events, etc.
- Supports the Corrective and Preventive Action (CAPA) System for Quality Operations-related activities.
- Applies knowledge in Quality Systems to execute overall project assignments.
- Applies statistical tools to analyze data and identify root cause and problem resolution.
- Collaborates with Manufacturing, Product Support and R&D to support products for design and process improvements, and new equipment installations.
- Recommends decisions on administrative or operational matters and ensures Quality Assurance(s) effective achievement of objectives.
- Ensures quality system compliance for areas of responsibility.
- Serve as a technical resource for assessing validation requirements, solving test related problems, and developing strategies for problem prevention.
- Perform and lead risk assessment exercises in support of validation activities.
- Bachelor’s degree in a technical discipline (Mechanical/Biomedical/Electrical engineering)
- Minimum 5 years’ experience in Manufacturing Engineering or Quality Engineering with preference having validation experience.
- Working knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO) - ISO 13485 and ISO 14971).
- Knowledge of DOE, SPC, Gage R&R, and sampling plans.
- Understanding of required standards / regulations impacting Medical Devices.
- Leadership ability and organizational skills.
- Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
- Must have experience handling nonconforming events
- SAP knowledge is a plus.
- Six Sigma Certification a plus.
- ASQ Quality Engineer Certification a plus
Established in 1995, PTS Advance provides people and tools to companies that want to do more than just "fill a position". Our expertise includes attracted and retaining key talent, while managing assignments in a safe, compliant, and transparent manner. We are honest and transparent in the process because we put you first.
Interested? Contact Allison Sudman at 949-268-4081 or via email at Allison.Sudman@PTSadvance.com for a confidential discussion!
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