QA Specialist III
Location: Buffalo Grove
Posted on: June 21, 2022
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
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