| Develop, release, and execute IQ/OQ Protocols for Fixtures and Tools.
Update and releases improvements/corrections to the quality management system documents for the validation of the manufacturing processes.
Design, procure and implement simple manufacturing aids and transport tooling.
Procure, Assemble Fixtures and Tools
Update documentation (CAD) for Fixtures and Tools and release in our PLM system.
Responsible for maintaining compliance with medical device quality system requirements including corrective action closure, discrepant material dispositions and ECO implementation.
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.
Skill/Job Requirements:
4 yr. degree in Mechanical Engineering or equivalent
Demonstrated Electromechanical and/or Process Engineering capability
Solid model experience (ProE or SolidWorks)
Strong foundation in design, fabrication and assembly of complex assemblies
Excellent communication and documentation skills
Demonstrated ability to represent the company to its partners, suppliers, and vendors
Comfortable interacting with technicians, engineers, and management
Strong technical skills in prototyping and troubleshooting from engineering documentation
Demonstrated ability to successfully work on multiple projects at once
ISO9001/13485 or experience in medical device manufacturing environment
Moving or lifting equipment/product up to 30 lbs. occasionally required
Machine tool experience a plus |
(IQ OR OQ OR IQ/OQ OR FIXTURES OR TOOLS OR DESIGN OR ASSEMBLY) AND ("MEDICAL DEVICE" OR "MEDICAL DEVICES" OR ISO9001) AND ("MECHANICAL ENGINEERING" OR "MECHANICAL ENGINEER" OR ELECTROMECHANICAL OR "PROCESS ENGINEERING" OR "PROCESS ENGINEER" OR "MANUFACTURING ENGINEER" OR MANUFACTURING) AND (SOLIDWORKS OR PROE)
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Mechanical or Industrial Engineering |
| • Understand, maintain, and contribute to the improvement efforts with document management processes for the BD Interventional Surgery; includes ensuring proper document templates are used, documents undergo appropriate review and approvals, documents are published with high quality standards; documents are appropriate circulated, and acknowledgements are accurately retained and well organized.
• Serve as subject matter expert for document management solution. Support efforts for implementation, training, troubleshooting, user-requests, and transition as needed.
• Prepare and maintain documents that support company and QA initiatives, such as process documents, policy documents, SOPs, templates, forms, tracking spreadsheets, meeting minutes, etc.
• Maintain quality document systems (e.g., EDMS, LMS, EPR etc.).
• Understand, maintain, and contribute to the improvement efforts with record management processes for the organization; includes ensuring record retention conventions and list are maintained and communicated, archiving room protocols are followed, and QA files are organized and maintained.
• Support QMS/QA related processes as directed. These activities are likely to include the following: Audits, CAPAs, improvement initiatives, Document Control, Record Control, Safety, QMS/Compliance Awareness and Training, Management Review, etc.
• Support customer audit/visit efforts as directed.
• Recommend quality improvements and suggestions.
• Must be able to work with different departments and individuals and help establish reasonable processes and programs to ensure compliance with all industry regulations and standards.
• Other duties and tasks that may be assigned on an as-needed basis.
• Strong interpersonal, communication and customer service skills.
• Excellent technical writing, grammar and speaking skills; ability to create and edit written material in a clear, concise, and accurate manner.
• Strong data analysis, problem analysis, and problem-solving skills.
• Ability to encourage progress, promote concepts, and maintain confidentiality.
• Strong attention to detail and appreciation for organization/order.
• Experience planning, organizing and implementing solutions that are sustainable.
• Willingness to actively collaborate, work independently, adapt to changes and changing priorities, and work under deadlines without sacrificing accuracy.
• Good time management, prioritization, judgment, and decision-making skills.
• Expert level knowledge of EDMS and LMS Systems.
• Experience with and/or quality systems / quality control compliance / ISO 13485 activities and or facilitating adult learning sessions, preferred.
• Industry specific experience preferred.
• Knowledge of tools, concepts and methodologies of QA preferred.
• Certifications that may include: Document Management Certified Professional, American Society of Quality (ASQ) Certified Quality Improvement Associate, Quality Auditor, or Six Sigma Green Belt, or similar. |
(Quality or QA or QMS) And (Document or Documentation or DMS) AND (Control or Maintenance or Development) AND ( EDMS or LMS or EPR ) And ( Record or Report or MBR ) AND( MS-Office or Excel or Word or Outlook) And( SOP)AND( CAPA ) AND(ISO 13485)AND((Lean or sigma or KAIZEN or Kanban or 5s or Green belt ) AND( Medical Devices )
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Medical Device |