Quality Technician - 2nd Shift

About this role

The Quality Technician will review device history records and approve final release documentation. This role will also complete appropriate quality records within company GMP and GDP guidelines, policies and procedures.

This role follows an onsite work model, requiring employees to be in our local office five days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

• Knowledge handling and reviewing device history records is a key responsibility in this position.
• Review incoming or production documentation for conformance that may include engineering drawings, schematics, and specifications; process standards and specifications; and production or process plans (IPC-A-610 certification is recommended).
• Knowledge handling Non-conformance documentation for manufacturing batch records and identifying GDP errors.
• Accept or reject device history records or first article inspection; identify and document non-conformance and notify appropriate personnel of potential rejection/correction of items.
• Refer/document unusual inspection problems to supervision, lead or Project Quality Engineer.
• Knowledge using a variety of measuring tools including electrical test sets, multimeter, fixed, limit, plug-gages, steel rules, scales, micrometers, calipers, and surface plate.
• Assist in the writing and updating of inspection procedures, protocol, and checklists.
• Transferring, releasing or quarantining material physically according to inspection status.
• Documenting and maintaining inspection and test records.
• Understand the importance of product conformity.
• Understand lot numbers and traceability.
• Understand ISO 13485 quality assurance standards and the related documentation in support of.
• Maintains safe and clean work environment by keeping shelves, workstations, etc. neat and complying with procedures, rules and regulations.
• Complete respective paperwork/documentation.

• Minimum of High School Diploma or AA degree in a scientific discipline and two years or more working experience in a relevant, cGMP/FDA regulated industry.
• Be able to identify GDP errors.
• Be able to apply and remove material labels.
• Be able to read and understand mechanical drawings and dimensions.
• Be able to read and interpret drawing notes and be able to understand configuration management (revision control).
• Be able to use basic measuring tools such as calipers, go-no/go gauges, torque wrenches, and others as necessary.
• Experience with electrical test sets, multimeter, vision measuring system is a plus.
• Experience working with an ERP system and data entry.
• Experience with Outlook and MS Office.
• Good communication and organizational skills.
• Must possess good math fundamentals, comprehend written work instructions, and communicate well.

• Knowledge of medical device records use within manufacturing.
• Working understanding of GDP and GMP.
• Excellent documentation skills, attention to detail and accuracy.
• Must be organized and able to coordinate activities with internal departments and outside vendors.
• Experience assisting regulatory inspections and/or audit.

The above descriptions are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. Boston Scientific utilizes the multi-skill concept and expects the employee to perform other job disciplines. Boston Scientific retains the discretion to add or change the functions and duties of the position at any time.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Nearest Major Market:
San Diego

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Compliance, Maintenance, Inspector, Data Entry, Quality Engineer, Legal, Manufacturing, Quality, Administrative, Engineering