Quality Engineer - Validation

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Base pay range

$95,000.00 / yr - $110,000.00 / yr

Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries. We leverage a long-standing experience to provide our clients with leading-edge drug delivery devices for different application areas, from services, design to large scale manufacturing.

Job Description

The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff.

Responsibilities

• Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency / effectiveness while minimizing cost
• Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
• Coordinate and manage the execution of validations and creation of written protocols.
• Coordinate and manage the execution of change control activities.
• Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.
• Utilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
• Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
• Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards.
• Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
• Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.
• Interact with suppliers and ensures mutual interpretation of specified requirements to make certain customer requirements and objectives are met.
• Support implementation and management of quality agreements with assigned suppliers.
• Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
• Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
• Assist the Quality Managers during customer audits and lead to final resolution any findings / observations resulting from the audits.
• Assist in maintaining ISO and FDA QSR quality systems compliance.
• Execute specific responsibilities as defined within the company quality operating system.
• Support and maintain all policies of the company, including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
• Identify and complete continuous improvement projects utilizing Six Sigma tools and methodologies.
• Other duties as assigned.

Preferred / Required Education / Skills

Work Environment

Qualifications

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. We take pride in our work because it improves patients lives.

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs in an international group. For more information about Nemera, visit .

PAY RANGE : $95,000 - $110,000 USD Salaried. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

Seniority level : Mid-Senior level

Employment type : Full-time

Job function : Manufacturing

Industries : Medical Equipment Manufacturing

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