Quality Engineer - Validation

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

About the role

The Quality Validation Engineer is responsible for planning, coordinating, and managing assigned projects to ensure the development and production of products meets customer and internal quality deliverables. This role involves coordinating and leading investigations regarding customer complaints, as well as working with Supply Chain management to evaluate and manage supplier performance. Duties 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, select 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 to ensure mutual interpretation of specified requirements and confirm 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 fulfillment of customer requirements and objectives.
• 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.

Requirements

• Bachelor’s degree in Engineering, Science, or related field required.
• 3+ years of experience in a Quality position strongly preferred.
• Experience in the Medical Device industry strongly preferred (ISO 13485).
• Experience with technical writing, IQ/OQ/PQ is preferred.
• Experience with equipment validation is preferred.
• Experience working onsite in Manufacturing is strongly preferred.
• Excellent communication skills with the ability to understand, read, write, and speak English required.
• Ability to apply advanced mathematical concepts and intermediate statistical (SPC) knowledge.
• Six Sigma experience, training, or certification preferred.
• Intermediate-level computer skills, including Microsoft Office applications required; SAP experience preferred.
• Ability to work independently from verbal and/or written instructions required.
• Ability to understand and articulate how individual role and responsibilities tie into Quality department function, goals, and objectives.

Work Environment

• Works in a clean manufacturing environment that may include moderate noise levels and requires appropriate PPE and cleanroom apparel.
• Ability to regularly lift up to 30 lbs with repetitive movements.
• Ability to push and pull items.
• Ability to stand, sit, and walk up to 80% of a shift.
• Ability to travel between office and production departments as well as company buildings required.
• Up to 25% travel required (some international).

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients’ lives.

Pay

$85,000 - $105,000 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.

Benefits

For US benefits, visit Nemera's benefits page.