Engineer, Sr Quality

Biotechnology and Pharmaceutical Engineer, Sr Quality Job Description:PURPOSE: Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support operational, or system/services support. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Provides leadership role on championing departmental or cross-functional engineering initiatives. Provides project direction, coaching, and mentoring for engineering and technical team personnel. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Mentor for technical guidance for identifying and resolving quality issues. Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues. Proactively investigate and analyze customer complaints. 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 with BS in Quality Engineering or related discipline. 1-3 years medical device experience required. Demonstrated used of Quality tools/methodologies including SPC, DOE, GR&R, FMEA, CAPA, complaint investigation, process validation (IQ, OQ,PQ) and FDA, ISO/MDD standards. Demonstrated interpersonal skills with ability to work within a team environment. Strong written/verbal communication skills. Proficiency in all Microsoft Office programs. PREFERRED REQUIREMENTS: The following are qualifications that we would prefer candidates to have. Six sigma problem solving methodologiesJob Experience:see descriptionMinimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: NoneThis company may offer relocation assistance. Please visit us online at www.bostonscientific.com for more information.