Boston Scientific Quality Engineer II 

United States, California, Sunnyvale 

576645520

Your responsibilities will include:

• Take responsibility for assigned Corrective and Preventive Actions (CAPAs) performing investigations, creating Corrective Action and Verification Plans, Implementing Corrective Action Plans, and Verifying Effectiveness of the actions.
• Initiate, investigate, and assist in generation and completion of NCEPs.
• Be a part of core project teams and lead the V&V engineering across the product development cycle
• Support the development of CTQ’s, design input and output documents
• Support project risk management, usability, reliability and design validation efforts for new product development and design change projects
• Support complaint investigation reports to help drive process improvements
• Function as a technical member of multidisciplinary project teams in the design, development, and manufacturing of energy based and non-energy based spinal products.
• Support supplier quality audits, internal audits, and external audits as needed.
• Work with Suppliers/Vendors on a regular basis for ongoing development projects
• Develop and assist others in the development of Quality System documents such as protocols, procedures, work instructions, and product specifications.
• Identify, prioritize and resolve quality issues identified by metrics.
• Manage electronic document control and version control on the Intracept product line and support project related documents

What we’re looking for in you:
Required Qualifications

• Bachelor of Science degree in any engineering discipline.
• 2+ years of experience in quality engineering or related engineering discipline.
• Experience with quality management systems in FDA, ISO 13485, and MDD/MDR regulatory environment.
• Problem solving skills are required.
• Ability to travel up to 10%

Preferred Qualifications

• Master's Degree in any Engineering discipline
• 2+ years of experience in the medical device industry
• Medical device experience with electro-mechanical devices and/or experience with injection molded components
• Demonstrated understanding of an engineering discipline.
• Knowledge in producing effective and timely quality assurance deliverables.
• Versatility, flexibility, and a willingness to work within constantly changing priorities in a rapidly growing environment with enthusiasm.
• Quality Engineering certification(s)
  

The expected annualized base pay range this full-time position working at this location will be from $77,100 - $146,400 plus annual bonus (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at BSC, which can be reviewed at . At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range. Boston Scientific considers various factors in determining actual compensation for this position at the expected location. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs. Actual compensation may be otherwise adjusted if the position is filled outside of the intended geographic location.

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

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.