Supplier QA Eng - P4

Boston Scientific; Dorado (PR); On-site; USD 64,000 - 121,000; Full time

Job summary

Boston Scientific is seeking a QA Engineer to drive supplier quality, implement design controls and risk management, and lead cross-functional teams across Quality, Operations, R&D, and Sourcing. The role requires a BS in engineering and 5+ years in regulated industries, with a focus on improving supplier performance and supporting component qualification.

This is an on-site position based in Puerto Rico with comprehensive benefits.

Qualifications

• BS degree in engineering with at least 5 years in related field.
• Experience in medical devices or regulated industries.
• Cross-functional project management across Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA.
• Independent, organized and self-driven.
• Articulate communicator and able to scale information for audiences.
• Problem solving and project management experience.
• Experience managing supplier quality issues and SCAR ownership.
• Experience monitoring supplier performance and supplier process changes.
• Fully bilingual.

Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
• Develops and/or sources inspection tools and equipment.
• Assists in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.

Skills

Quality Assurance

Project Management

Supplier Quality

Process Validation

Design Controls

Risk Management

CAPA

Bilingual

Education

BS degree in engineering

Job description

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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.

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Key Responsibilities

• Assess potential new suppliers for technical, quality and manufacturing capabilities. Provides technical support for the introduction of components from a new supplier.
• Generates and maintains incoming inspection procedures. Trains inspectors to these procedures.
• Develops and/or sources inspection tools and equipment.
• Assists in generating component specifications.
• Generate test protocols, monitor testing, issue qualification test reports and approve components for use in products.
• Provide input to Design Engineering on new component technology and assist in component selection with quality and reliability analysis.
• Analyses incoming material defects. Dispositions and drives corrective action as necessary. Communicates issues to suppliers.
• Reviews new design specifications and provides input from component quality and manufacturability perspective.
• Investigates field failures related to supplier materials. Develop corrective action plan where necessary.

Management Requirements

• BS degree in engineering with a minimum of 5 years of related experience or an equivalent combination of education and work experience.
• Experience in medical devices or other regulated industry.
• Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA
• Ability to work independently; organized and self-driven.
• Articulate communicator: adept at packaging and appropriately scaling information to the intended audience.
• Problem Solving and Project Management experience
• Experience managing supplier quality issues, including supplier nonconformance escalation and SCAR ownership.
• Experience monitoring supplier performance and supporting continuous improvement activities.Experience supporting component qualification and supplier process changes.
• Fully Bilingual

Requisition ID:636052

Minimum Salary:$63800

Maximum Salary: $121200

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 transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.

Nearest Major Market: Puerto Rico
Nearest Secondary Market: San Juan
Job Segment: QA Engineer, Quality Assurance, QA, Project Manager, Inspector, Engineering, Technology, Quality