Senior Quality Engineer

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 CV to the following email address: or call Rose Chu at 215-317-2999 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.

• 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.

• 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 215-317-2999 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: 215-317-2999