Manufacturing Operations Specialist - ENG

Integra LifeSciences Holdings - Anasco, PR

Anasco, PR

Miscellaneous Manufacturing

About the position

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Responsibilities

• Provides support to the manufacturing area with the required technical support, process control and methods.
• Solves practical problems encountered in fields executing technical functions required including troubleshooting and process improvement in the manufacturing area.
• Evaluates questionable raw material, rejected units or non-conformances and/or CAPA's reported by manufacturing employees by inspecting and testing as needed.
• Responsible for monitoring the process yield and support Manufacturing Engineers in the developing and implementation of the scrap reduction initiatives.
• Directs and document investigation to correct non-conformances and or CAPA's, product quality issues and low yields under close supervision.
• Develops and leads multiple activities within complex projects as required.
• Develops and leads process improvement projects and small validations under close supervision.
• Assists in the installation and start-up of new equipment.
• Assists in failure investigation and problem-solving exercises to identify effective corrective and preventive action (CAPA) to reduce product defects and customer complaints.
• Works closely with Quality Engineers in process control initiatives in order to prevent non conformances.
• Performs special assignments and other duties assigned by supervisor.
• Investigate non-conformance (NCR) report in a timely manner as required.
• Keeps manufacturing instruction, standard operational procedures and engineering process sheet updated as needed.
• Develops manufacturing instructions, standard operational procedures and submits changes in order to improve operational performance.
• Trains employees in manufacturing instructions, operational procedures changes and equipment use.
• Assists in compiling observations, analyzing data and interpreting test results.
• Generates purchase requisitions for new equipment, materials, machinery, services, spare parts and production supplies to supervisor for approval.
• Recommends the incorporation of new technology applications where feasible and practical within the manufacturing area.
• Maintains and update working knowledge of all required process and product specifications.
• Maintenance and update of manufacturing documentation such as: BOM/production routers, procedures, drawings, specifications, etc.
• Maintenance and upgrade existing products/processes.
• Develops, coordinates, and implements the change controls related to each manufacturing engineering project.
• Develops the required documentation, procedures, drawings, protocols, engineering change notices, technical reports and other information as required by the company.
• Evaluates, investigates and documents non-conformances/CAPA incidents.
• Completes assigned Non-Conformance and CAPA investigations and prepare investigation reports and subsequent documents.
• Development of process controls for new and existing equipment and/or processes.
• Develops and implements Six Sigma/Lean projects and quality improvement plans.
• Participates in the compilation and review of technical documentation for both domestic and international regulatory submissions.
• Participates in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
• Performs other related duties as necessary.

Requirements

• Associate degree (minimum) in Engineering, Sciences or Quality Control.
• BS in Engineering (Mechanical, Industrial, Electrical, Chemical, or Biomedical) or Sciences is a plus.
• Lean/Six Sigma Yellow or Green Belt Certification preferred.
• Minimum of 3 - 5 years of experience in the medical device and/or pharmaceutical manufacturing environment.
• Knowledge in Collagen and Silicone technologies and materials as well as lyophilization and dispersion preparation is desirable.
• Strong knowledge in quality improvements tools and problem-solving techniques (root cause analysis).
• Must understand and be able to apply the elements of corrective and preventive actions, including root cause analysis, failure mode and effects analysis (FMEA), and the control of nonconforming material.
• Initiate and implement preventive and corrective actions and perform the appropriate verification of effectiveness.
• Must understand and be able to apply basic inspection and testing techniques, including various types of sampling plans.
• Strong investigations and technical writing skills.
• Basic knowledge in statistical techniques, sampling plan and statistical process control.
• Basic knowledge in Organizational Excellence and Lean/Six Sigma.
• Basic knowledge in validations field.
• Must understand and be able to apply basic inspection and testing techniques, including various types of sampling plans.
• Must be able to read and interpret blueprints (drawings).
• Must know which measurement and test equipment (M&TE) tools are appropriate for various tasks and how to assess tool accuracy and precision.
• Teamwork oriented and self-starter.
• The ability to effectively manage/lead multiple priorities is a must.
• Strong communication skills (oral and written) and proficient in English language.
• Availability to work extended hours in the day and weekends as required.