Quality Engineer - Medical Devices

Location: Arlington

Quality Engineer
- Medical Devices

Reports To:

Quality Assurance Manager

Department:
Quality

Division:
Northern Division

Location:

Headquarters

Summary:

Provides quality engineering support during new business development, program launches, and for existing customers. The Quality Engineer will ensure that manufacturing processes, quality systems, and finished products for medical devices meet all applicable regulatory, customer, and internal quality requirements.

* This role involves working in an ITAR-controlled environment. The successful candidate will have a strong technical background, problem-solving skills, and the ability to work within the strict compliance requirements of ITAR regulations.

Essential Duties and Responsibilities:

* Support new business development

* Provides support to new business development relating to quality matters as needed.

* Draft preliminary Quality Plan, if appropriate.

* Provides cost and time estimates for anticipated quality department services such as metrology or validation services.

* Functions as a resource for CFR Part 820 and ISO 13485 regulatory requirements.

* Support Program Launch and Product Realization as functional department representative assigned to team and Program Manager

* Reviews new program drawings/information/customer specifications to understand program requirements.

* Support customer audits, regulatory inspections, and certification.

* Drafts program Quality Plan, PFMEA, and Dynamic Control Plans as required.

* Drafts other required quality documentation such as Dimensional Visual Quality Requirements (DVQR's) and new product inspection techniques.

* Confirms customer agreement on GD&T callouts/interpretations and all critical dimensions of program when required.

* Prepares manufacturing job travelers and associated process documents.

* Develops required Control/Test methods.

* Ensures First Article Inspection (FAI) and Capability Studies are scheduled and completed.

* Completes FAI and capability study analysis for submission to customer.

* Generates validation plans, operational qualification (OQ), performance qualification (PQ) protocols, and provides training for protocol participants.

* Oversees the execution of assigned validation activities to ensure compliance with protocol requirements and completion of study tasks.

* Generates Required validation completion reports to include resolution of any deviations recorded and overall study conclusion.

* Perform first-piece and in-process approvals for new setups, tooling changes, or process adjustments.

* Attends program team meetings to support production-related matters.

* Performs assigned activities in a timely manner.

* Provide continuous quality engineering support through program end of life.

* Completes Certificates of Conformance (CoC) for outgoing products, where required.

* Collects and analyzes production line data to monitor yield and defect performance.

* Use statistical tools (SPC, DOE, capability studies) to identify process improvement opportunities.

* Maintains Device Master Records including Device History Records as required.

* Performs periodic risk assessments, as required.

* Assists Purchasing Department with maintaining vendor quality requirements.

* Continuously monitors production to identify quality-related customer issues and supports corrective action plans when necessary.

* Issue or authorize customer complaints and returns as needed. Manages the return of goods, assignments and close out of RC/CA.

* Documents nonconformances, conducts thorough root cause analyses, and develops and implements effective corrective action plans.

* Manages product and process change control and notification to ensure required Engineering Change Orders (ECOs) are generated and approved by the customer prior to implementation.

* Attends program team meetings as necessary to resolve program quality issues to maintain customer satisfaction.

* Support quality business reviews with customer and provides/presents quality-related topics.

* Participates in customer, certified body, and regulatory audits as a subject matter expert for assigned products and processes.

Has a working knowledge of:

* Statistical techniques and tools (Minitab) and sampling plans.

* Strong analytical and root cause problem-solving skills (5-Whys, Fishbone, 8D).

* Quality Systems Regulations and ISO Standards.

* Advanced Product Quality Planning (APQP)

* Multiple manufacturing processes (e.g., injection molding, machining, assembly, packaging).

* Occasional domestic travel required.

* Other duties as assigned.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Analytical - Collects and researches data;
Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner;
Gathers and analyzes information skillfully;
Develops alternative solutions.

Customer Service - Manages difficult or emotional customer situations;
Responds promptly to customer needs;
Responds to…