Quality Technician - 2nd Shift

Position: Quality Technician I - 2nd Shift
This job is with Boston Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Additional Location(s):
N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

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 (Good Manufacturing Process) and GDP (Good Documentation Practice) guidelines, policies and procedures.
The Quality Technician performs inspection, in-process inspections, and final inspections, review of device history records of manufacturing/batch records per control/quality plans
The Quality Technician will keep track of Non-Conformance material and documentation, place or remove required label of the product/materials involved in the non-conformance.
Work Mode
At Boston Scientific, we value collaboration and synergy. This role follows a onsite work model, requiring employees to be in our local office five days per week.

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

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

Your responsibilities will include:

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 (Good Documentation Procedures) 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.

Required Qualifications:

Education:

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.

Require

Experience:

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 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, Skills, and Abilities:
Knowledge of medical device records use within manufacturing
Working understanding of GDP and GMP
Excellent documentation skills, attention to detail and accuracy
Team player, flexible multitask, good written/oral communicator
Must be organized and able to coordinate activities with internal departments and outside vendors
Experience assisting regulatory inspections and/or audit

Other Duties/Standards:

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…