Mechanical Engineer
Listed on 2026-07-08
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
- Shift /
Schedule:
8:00 AM – 5:00 PM, Monday–Friday - Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Location: Newark, DE
Onsite Flexibility: Onsite
Contract Details- Position Type: Contract
- Contract Duration: 12 months
- Pay Rate: $75.00–$100.00 / Hour (USD)
- Shift /
Schedule:
8:00 AM – 5:00 PM, Monday–Friday - Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
This role designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products.
Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Performs hands-on troubleshooting of electro-mechanical medical devices to identify root causes to non-conformances that occur during the manufacturing processes.
A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments.
Key Responsibilities- Responsible for identifying, diagnosing, prioritizing, and correcting technical issues that may arise in standard manufacturing processes; works in conjunction with other departments where appropriate.
- Evaluate and develop process control data for trending analysis; analyzes defects, provides feedback, and implements process improvements.
- Participates in design reviews, working with R&D and manufacturing to resolve all issues, particularly those arising from the violation of design standards or changes from existing manufacturing procedures.
- Actively supports and adheres to the Quality Policy and Quality System procedures.
- Identify and lead complex projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs.
- Write & Execute and Coach Others on how to perform TMVs.
- Write & Execute and Coach Others on Complex Change Orders (procedure updates, validations, clarifications, etc.).
- Lead/Own Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOPs/documents, etc.).
- Write & Execute and Coach Others on how to perform PQs.
- Lead/Own CAPAs and HRAs/HHEs.
- Model all quality values and coach others on BSH quality system requirements and standards to elevate the team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste, and provide for continuous improvement; collaborate and communicate effectively with junior level employees, peers, and cross-functional teams across all levels of the organization.
- Collaborates with Operations, Engineering, and R&D; accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
- Accountable for the development, training delivery, and monitoring of procedures, investigation procedures, and test methods in compliance with QMS, Medical Device Quality System Regulation, and…
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