Quality Technician I

Boston Scientific; Carlsbad (CA); On-site; USD 39,000 - 67,000; Full time

Job summary

Boston Scientific in Carlsbad, CA is hiring a Quality Technician to review device history records, approve final release docs, and ensure GMP/GDP compliance. The role involves in-process and final inspections, and managing non-conforming materials.

Two shifts: 6:00am-2:30pm and 2:30pm-11:00pm; onsite five days a week. Candidates should have high school diploma or similar and experience with measuring tools, drawings, ERP, and MS Office.

Qualifications

• High School Diploma or AA in a scientific field with 2+ years in cGMP/FDA setting.
• Ability to identify GDP errors and understand drawings.
• Experience reading mechanical drawings and dimensions.
• Proficient with calipers, gauges and basic measuring tools.
• Experience with ERP systems and MS Office.
• Good communication and organizational skills.

Responsibilities

• Review device history records and approve final release documentation.
• Inspect in-process and final products and review related documentation.
• Identify and document non-conformances; notify appropriate personnel.
• Maintain inspection records and support GDP/GMP compliance.
• Operate measuring tools including micrometers, calipers and gauges.
• Assist in updating inspection procedures and checklists.
• Ensure safe, clean work environment and proper labeling.

Skills

Quality inspection

Documentation

GDP/GMP knowledge

Reviewing device history records

Non-conformance handling

Reading drawings and dimensions

Measuring tools usage

Communication skills

Education

High School Diploma or AA in scientific field

Tools

Electrical test sets

Multimeter

Vision measuring system

ERP system

MS Office

Outlook

Job description

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.

1st Shift - 6:00am-2:30pm

2nd Shift - 2:30pm-11:00pm

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.
• 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
• 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 discretion to add or change the functions and duties of the position at any time.

Requisition ID:636866

Minimum Salary: $ 39416

Maximum Salary: $ 66976

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com— will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

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