Senior Quality Engineer

3 weeks ago

Elkton, United States Experis Full time

A leading global medical device company is looking for a Sr. Quality Engineer  to start ASAP. Sr. Quality Engineer required to work in Elkton, MD (Hybrid schedule after training). This is a Direct-Hire opportunity (NO sponsorship)  Interested individuals are encouraged to contact or submit their RESUME to the following email address: or call Rose Chu at (phone number removed) for discussion.

Job Summary:

Responsible for investigating, planning, and implementing improvements in and/or additions to current products and manufacturing processes that directly affects safety, quality, and productivity with the end result of producing a better quality product more efficiently.

Ensure compliance to quality policy, respond to customer complaints, perform audits, develop test methods, and/or write procedures for material characterization.

Job Details:

Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.

Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities.

Establish effective corrective action plans. Lead in implementation of quality assurance plans, process controls, and CAPA systems designed to meet or exceed internal and external requirements.

Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Review and approve product and process qualification and validation and other change control related documentation.

Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements

Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures.

Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.

Performs analytical measurements and experiments to qualify or resolve product and process issues.

Will be responsible for developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements.

Track quality trends and initiate action items to resolve issues. Manage assigned corrective actions.

Position Requirements:

Bachelor’s degree in Engineering, Quality, or another related field, with at least 6-8 years of experience in a Quality Engineering role.

Previous Medical Device industry experience preferred, not required

A strong understanding of ISO 9001 and ISO 13485 standards is required, as is experience with quality assurance tools such as FMEA and SPC.

Highly organized and detail-oriented, with excellent communication and problem-solving skills.

Please forward your credentials in Word format by email your resume directly to  or call Rose Chu direct at (phone number removed) for questions. Our technical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.

Rose Chu

Pharma, CRO and Medical Device Service

Experis

C: (phone number removed)

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