Insulet Corporation

  • Manufacturing Quality Engineer

    Job Locations US-MA-Acton | US-MA-Acton
    Posted Date 1 month ago(11/1/2018 9:03 AM)
    Category
    Quality Assurance / Quality Engineering
  • Position Summary

    The Sr. Manufacturing Quality Engineer will be a critical contributor in a mission that truly represents an once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.

     

    The successful candidate will be responsible for providing Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. It requires creativity and foresight to work with other functions to ensure compliance and the accomplishment of departmental and company goals. The position requires working alongside with engineering, purchasing, suppliers, and manufacturing to support the manufacturing operations and continuous improvement initiatives.

    Responsibilities

    • Assist in designing, building, and managing the facility Quality System to achieve compliance with ISO13485, ISO14971, 21 CFR part 820 and 11.
    • Performs and documents Root Cause investigations related to product and components rejections. Formulate corrective and preventive actions; implements those actions in order to improve quality levels and regulatory compliance.
    • Act as a backup Quality Manager as needed
    • Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification/validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.
    • Write and review protocols and reports of Process and Test Method Validations. Design, complete protocols and write reports for gauge R&R analysis.
    • Write and review quality documentation such as procedures, test protocols and reports.
    • Prepare reports by collecting, analyzing, and summarizing data. Analyze data and make decisions using valid statistical techniques.
    • Assist in the creation of statistical techniques for metric generation methods.
    • Assist in the development of risk based assessments to determine inspection requirements and acceptance criteria.
    • Establish statistical confidence by identifying sample size and acceptable error; determine levels of confidence.
    • Support operations/manufacturing by resolving process and material related quality problems in support of the various manufacturing departments.
    • Work with operations/manufacturing and the contract manufacturer to lead efforts to resolve issues that involve quality system gaps, production non-conformances or situations that involve component qualification or procurement.
    • Work with department leads in identifying and establishing quality related metrics.
    • Assist in the development of process monitoring and measurement tools.
    • Establish ownership responsibilities for issues and non-conformances and develop expertise in Master Control to coordinate resolution of the issues and non-conformances.
    • Generate and maintain Quality System documentations (SOPs, procedures, forms, work instructions, etc.)
    • Enhance quality system processes as it pertains to management of assigned deliverables to ensure compliance.
    • Supervise Quality Technicians.
    • Train plant employees on new processes and programs (SPC, visual aids, new procedures, best practices, etc.)
    • Expected to be able to manage critical projects with little or no direction from QA manager.
    • Support plant cost reduction and process improvement projects through the use of various quality tools such as FMEA, process capability, Gauge R&R, Chart analysis etc.
    • Apply SPC methods for analyzing data to evaluate the current process and process changes
    • Be an active lead auditor, participating in external supplier audits and internal audits.
    • Develop and/or manage some quality programs related to resolution of issues arising from manufacturing operations as well as post manufacturing activities. Provide QA Engineering support and expertise to Manufacturing, Engineering, and other company functions.
    • Work with and guide the team performing incoming inspection, in-process control and final product testing and release to ensure deliverables of product release are met.
    • Support activities as it pertains to sterilization release, sterilization validation, biocompatibility, design verification, design validation and other associated validation and qualification activities.
    • Track and prepare reports related to Quality Metrics and identify and implement improvements towards meeting those goals.
    • Presents quality data to Management
    • Actively work within the CAPA system, provide inputs to the CAPA Review Board and Monthly Data Analysis.
    • Perform other duties as assigned.

    Education and Experience

    Minimum Requirements:
    • BS degree in engineering, a technical or scientific discipline.

     

    Preferred Skills and Competencies:
    • Minimum of 3 years in the Medical Device Industry, specifically in a Quality function working with QSR and ISO 13485.
    • Experience with FDA and ISO 13485 inspections.
    • Demonstrated experience/results in Quality System tools and problem solving.
    • Six Sigma and Lean Certification.
    • Effective verbal and excellent technical writing skills.
    • Ability to communicate and work effectively at multiple levels within the organization.
    • Must be able to multitask and prioritize autonomously
    • Ability to organize and judge priorities.
    • Excels at generating and maintaining organized and accurate records.
    • PC skill, word processing, spreadsheet, database.
    • High-mechanical aptitude and knowledge of device manufacturing methods are strongly preferred.
    • Knowledge of applied statistics (sampling plans, Cpk, population comparison, confidence analysis etc.) required.
    • Proficient in Statistical Software for data analysis (Minitab preferred)

     

    Physical Requirements (if applicable):

    • While performing the duties of this job, the employee is regularly required to sit, stand, and walk.
    • Employee must occasionally lift and/or move up to 50 pounds.
    • Able to travel internationally (10%)

     

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