Sr. Manufacturing Quality Engineer

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Fahrenheit IT
Quality, Engineer, Engineering, FDA, ISO, Validation, Medical Device, IT
Contract W2
Work from home not available Travel not required

Job Description

Id: 166413 Location: Elkton, MD Job Type: Contract Our client, a leading global medical device company is hiring for a Senior Manufacturing Quality Engineer to work in Elkton, MD office. The individual MUST have the ability to hit the ground running (after a brief training period).

This is a full-time (40 hour per week) on-site contract opportunities based on W2/1099/Corp-to-Corp. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact us at or and call Rose Chu, VP in Pharmaceutical & Biotech Services Group at #610-822-1256 for questions.

We are always interested in talking to candidates for current AND future opportunities! Please respond directly to Global Employment Solutions, Inc. at with your resume attached -WORD document.

Sr. Manufacturing Quality Engineer resource

We are in need of a Senior Manufacturing Quality Engineer contractor for a long-term contract estimated. Need Quality Engineer who has done quality on a production floor of a medical device company, with strong CAPA and NC experience. Need ASAP. We welcome W2/1099 and Corp-to-Corp consultants. Market rate, PHONE interview to HIRE.

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 Terumo's 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.
Monitor field quality and analyze field returns to determine root cause .
Provide training and support for quality system processes and quality engineering practices.

Position Requirements:

Requires a minimum of a 4 year degree in engineering, life sciences, or similar.
Requires six to ten years increasing responsibility and experience in a medical device quality assurance environment.
Prefer one to two years of auditor experience
Prefer certification as a CQA, CQE, or CQM , and member of the ASQ.
Communication skills both verbal and written.
Organizational skills as well as time management skills essential for project work.
Excellent computer skills. Strong writing, mathematics and statistics skills

Keywords: Sr. Quality Engineer, Senior Validation Engineer, Medical Device Quality Engineer, Senior Quality Validation engineer, program associated with manufacturing, GMP

We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Sr. Medical Device Quality Engineer ) in the subject line of your correspondence to ensure review.

Please forward your credentials in Word format, in confidence, to: Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.

Rose Chu

Vice President - Pharmaceutical, CRO, Biotech, Medical Device

Global Employment Solutions/Fahrenheit IT

P (610)822-1256 | C (215)-317-2999 | F (610-668-5000) |

One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004

We're looking for hot talent! Tell your friends and get $250 plus

Company Information

Founded in 1998, Fahrenheit IT specializes in IT consulting and direct hire staffing solutions. The company delivers the highest quality technology professionals and an array of customized IT talent solutions designed to improve productivity and drive results. The Company is deeply integrated in the communities it serves and combines significant local market intelligence with the support and resources of a nationwide company.
Dice Id : 10111360
Position Id : 166413
Originally Posted : 8 months ago

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