Quality Engineer II Shift B at Boston Scientific Corporation Malaysia

, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

02 Feb, 26

Salary

0.0

Posted On

04 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Root Cause Analysis, Process Improvement, Statistical Techniques, CAPA, FMEA, Validation Protocols, Technical Drawings, ISO Standards, cGMP, Six Sigma, Lean, Problem Solving, Inspection Techniques, Statistical Sampling, Quality Systems

Industry

Medical Equipment Manufacturing

Description

May execute the following resposibilities:Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria. Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs. Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation. Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials. Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc. Evaluates new equipment and processes and participates in the transfer of new products. Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation. Read and interpret technical drawings, procedures, and protocols Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness). Document investigation findings in analysis report on GCS2 Become a trainer for the Software related with complaints handling process (GCS2), as required. Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities Provide supervision, leadership, and overall direction to the Quality Release team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process. Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. For those individuals that supervise others, the following statements are applicable: Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System. Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field English Level required: B2 (70% - 79%). Desired knowledge: desirable ASQ Certified, ASQ certification (CQE, SSGB) desired, problem solving, Knowledge of QSR's, Formal training on statistical and quality techniques desirable, Networking, Statistical skills, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods. Scientific tools (e.g. Gage R&R, DOE, process capability, SPC), Formal training on statistical and quality techniques desirableASQ certified, knowledge of Six Sigma, Knowledge in Lean, APQP or similar 1 year or more in current position. Annual Performance evaluation rating "Meets Expectations" or "Exceeds Expectations". CYLTA #CRTA #QACR Requisition ID: 614965 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Responsibilities

The Quality Engineer II is responsible for identifying manufacturing process defects and working with process owners to ensure product quality. They will also support validation activities and lead the Quality Release team to maintain compliance with quality standards.