QA Specialist III

Company: Mindlance
Location: Buffalo Grove
Posted on: June 21, 2022

Job Description:

Job Description MAIN PURPOSE OF ROLE Summarize the main purpose of the role. This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. MAIN RESPONSIBILITIES ---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 ---Lead, coach, and mentor non-exempt and entry level exempt personnel ---Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues ---Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues ---Design and conduct experiments for process optimization and/or improvement ---Appropriately document experiment plans and results, including protocol writing and reports ---Lead process control and monitoring of CTQ parameters and specifications ---Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing) ---Lead the investigation, resolution and prevention of product and process nonconformances ---Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member) ---Lead in the completion and maintenance of risk analysis ---Work with design engineering in the completion of product verification and validation ---Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities ---Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements ---Performs other related duties and responsibilities, on occasion, as assigned. QUALIFICATIONS Education Education Level Major/Field of Study Or Education Level Bachelors Degree ( - 16 years) Engineering or Technical Field n equivalent combination of education and work experience Experience/Background Experience Experience Details Minimum 5 years Demonstrated supervisory experience preferred. Engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971. Solid communication and interpersonal skills. Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience preferred. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing). Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance.

Keywords: Mindlance, Buffalo Grove , QA Specialist III, Other , Buffalo Grove, Illinois