Engineer II, Quality - 100431 - Spencer,IN - 0300 Posted Date: August 22, 2013



Job Description

PURPOSE:
Provides focused quality engineering support within appropriate engineering group, manufacturing, system/services support and the materials group. Develops, establishes and maintains quality engineering metrologies, 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 quality goals and priorities. Provides focused quality engineering support within operational and system/service support for the Urology/ Oncology/Endo-Surgery business unit and other areas.
 
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.
·         Establish effective corrective action plans. Lead in implementation of quality assurance plans, 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.
·         Review and approve product, process, software qualification and validation and other change control related documentation.
·         Develop product/process assurance plans, which include all required elements. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
·         Generate internal quality documentation such as quality plans, standard operating procedures and inspection procedures. Ensure BSC regulatory, FDA and ISO compliance in all areas of responsibilities.
·         Participate in Product Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
·         Must comply with requirements of ISO 14001 and BSC Environmental, Health and Safety standards and follow procedures and instructions related to these standards.
 
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:   EDUCATION, EXPERIENCE, and/or SKILLS
Position requires a minimum of a BS / BA from a four-year college or university and a minimum of 3-5 years experience in a quality or related field. Strong written and verbal communication skills are desired. Previous demonstrated use of Quality tools and methodologies.
 
PREFERRED:
 
Six Sigma problem solving methodologies