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in Elkton, MD
Senior Quality Engineer
•14 days ago
Hours | Full-time |
---|---|
Location | Elkton, Maryland |
About this job
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