Manufacturing Quality Engineer
Website BD
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Qualifications
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Required: Bachelor of Science degree
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Required: 3 years manufacturing experience with broad background in manufacturing processes
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2 years Process Control experience
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2 years Quality manufacturing experience
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Proven history of product / process improvements utilizing Green/ Black Belt/Six Sigma techniques
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Ability to generate validation protocols, which align with the globalization standardization initiative
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3 years practical GMP / Medical Device manufacturing experience
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Responsibilities
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To assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality
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To use problem solving techniques to increase quality and productivity within the business
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Crucial responsibilities include but are not limited to:
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Develop, change, and supervise in-process inspections to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements
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Process monitoring and adjustment, process and product improvement, including corrective action plans to address complaint issues
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Documentation of these activities along with the review and maintenance of S.O., O.I.s and department specific operating procedures such as manufacturing cleaning procedures
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Employee training of Quality Control concerns regarding Process specifications
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Develop and implement procedures applicable to the total plant manufacturing process
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Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines
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Assistance in such areas as process validation, process acceptance, certain audit correction actions, Change Control issuance for process changes
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Support CAPAs as owner or as part of the support team
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Monitor the performance of assigned product lines about product quality levels, waste, and rejection rates
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Leading / mentoring / conducting quality improvement projects thru CI initiatives
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May acquire Green/Black Belt Certification
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Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost
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Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement
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Develop programs for the maintenance, replacement, and improvement of inspection gauging
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Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices
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Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements
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Own and continue to improve department training systems
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Monitor customer complaints and trends
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Respond as needed for specific corrective action and customer interface
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Provide support and guidance on quality/ process improvements
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Ensure that all company safety rules and regulations are followed and promote general plant safety
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Own and lead efforts to reduce and eliminate rejections
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Assist in internal/ external audits and supplier certification processes as needed
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Other duties, as assigned
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Supervision of QC Representatives & other support personnel necessary for assigned project completion
Benefits
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We have a variety of plans including a new HSA Basic plan option with Cigna
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$0 payroll contributions if your salary is below $50,000
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Plan covers 100% preventative care (annual wellness exam, and immunizations)
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BD provides comprehensive total rewards benefits for all of its employees
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Most benefits start on day 1 of your employment with BD
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Up to 6 weeks of paid parental leave
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Medical, dental, and vision insurance plans
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Education assistance ($5250.00 per year)
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Adoption assistance
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401K plan with $.75 of every dollar matched up to 6% of compensation
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Basic life and AD&D provided
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Discounted home, auto, and pet insurance plans
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Paid holidays and vacation (pro-rated the first year based on actual start date)
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To apply for this job please visit www.google.com.
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