Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Sr. Software Quality Engineer
Description
PURPOSE:
Develops, establishes and maintains software validation quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate software validation quality goals and priorities. Provides focused quality engineering support within new software systems development, operational, or system/services support.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Identify software/systems that require validation and categorize each based upon business risk.
· Perform compliance assessments and issues reports on plant software inventory.
· Support software validation processes including identification of deficiencies and implemented corrective actions.
· Act as the plant site lead for all Corporate software initiatives and compliance activities.
· Lead in the implementation of software validation assurances and software process controls designed to meet or exceed internal and external requirements.
· Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
· Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
· Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
· Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
· Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
SUPERVISORY RESPONSIBILITIES:
May supervise or coach technicians or other engineering support employees. Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
MINIMUM REQUIREMENTS: To be considered for this position you must have the following qualifications: EDUCATION, EXPERIENCE, and/or SKILLS
5-8 Years experience in medical device industry with BA/BS in Quality Engineering, Computer Science or related discipline.
Strong written/verbal communication skills.
Knowledge of FDAGMP guidelines. Demonstrated use of Quality tools/methodologies including: Software Validation, Process Validation, Risk Analysis, Process FMEA, software life cycles (development) and Statistical Analysis.
PREFERRED REQUIREMENTS: The following are qualifications that we would prefer candidates to have.
CSWQE or CQE certification. Knowledge or experience with IEEE software guidelines, programming languages and bug tracking tools.
