Sr. Process Improvement and Technology Engineer

Sr. Process Improvement and Technology Engineer
Requisition City:Andover
Company Order Number:978
# of openings:1
Position Summary:
Provide support to Quality and Manufacturing in areas of process improvement and technology. Participate in activities such as developing new automated processes, technology transfer of new products, equipment qualification, process validation, software validation, risk analysis, failure investigation, internal audits, metrics, material testing, process monitoring, product monitoring, and other duties as assigned by the head of Process Improvement and Technology.
Major Responsibilities of the Position:
+ Assist with development and implementation of process improvement projects
+ Support qualification / validation efforts as defined in Validation Master Plan for new products and processes; provide complete, accurate, and well organized documentation for requirements, plans, reports, PFMEA?s, checklists, etc. as determined by validation teams
+ Support technology transfer of processes / articles by providing complete, accurate quality documentation; this includes sampling plans, process controls, test methods, measurement techniques, and evaluation criteria throughout the manufacturing process
+ Process owner for SLA/SLActive quality assurance laboratory; this includes surface topography, hydrophilicity testing, and product vial testing
+ Participate in the audit program as required
+ Back-up to process owner for all environmental and biological monitoring; this includes bioburden, particle counts, elemental surface analysis, and product cleanliness tests
Other Duties:
+ Identify areas for improvement; recommend and implement solutions
+ Support on-going compliance through re-validation evaluation
+ Maintain job related processes / work instructions
+ Support NCMR?s, ECO?s, CAPA?s, required
+ Participate in meeting departmental goals and objectives
+ Other duties as may be assigned by the head of Process Improvement and Technology
Minimum Qualifications:
+ Bachelor?s degree in engineering or related field
+ Minimum 10 years experience as an engineer in a related field
Required Knowledge and Skills:
+ Working knowledge of validation, failure investigation, PFMEA, GR&R, auditing, quality assurance, and quality systems in a medical device environment
+ Working knowledge of QSR and ISO standards
+ Effective verbal and written communication skills
+ Analytical problem solving skills
+ Interpersonal skills
+ Word, Excel, Project, statistical software computer skills a74233a939df47fbb87fb080c249c0c7

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