Site Quality Lead/Site Engineer - QA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Warehouse

Job Description

How will you make an impact?

The Quality Site Lead will lead in the implementation of quality assurances practices, process control, change control, and Corrective and Preventive Action activities. This position is embedded in the Operations Work Stream. The Quality Site Lead will partner with Operations and is the primary point of contact for all Quality decisions affecting daily activities. The Quality Site Lead will approve investigations, deviations, change controls, and in-process control improvements. In addition, they will evaluate and recommend process changes to improve the Value Stream performance and regulatory compliance. The Quality Site Lead will act as an effective leader in promoting quality disciplines, decisions and practices, and will apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

Location: Oakwood Village, OH

Relocation assistance is NOT provided. 

What will you do?

• Provide Quality input to all investigations, deviations, change controls, SOP’s, and in-process controls in support of the assigned Value Stream(s).
• Enable collaborative relationships between Operations and Quality with the overall focus of improving customer satisfaction.
• Troubleshoot process issues. Lead inter-department teams in the resolution of process issues and quality problems.
• Work as a member of new product introduction teams to provide quality input and capability analysis.
• Work closely with Operations, R & D, Purchasing, and Engineering to improve quality while reducing material scrap and costs.
• Champion continuous improvement and the transition to a Lean Manufacturing Environment.
• Drive quality management focus on productivity improvements throughout the business unit.
• Work effectively as a member of cross-functional teams.
• Partner with Operations leadership to establish controls and inspection points to facilitate detection, correction, and prevention of nonconforming materials, parts, assemblies, and products.
• Drive Customer complaints to resolution; Serve as Quality Representative for all quality-related corrective/preventive actions within the Value Stream.
• Lead PPI activities at the site including the facilitation of Kaizen events. Supports Operations and Quality team members on process improvement activities.
• As the designated Management Representative for the Oakwood Village site, interact with all agencies and institutions that regulate or assess the Microbiology Division quality system and regularly report the effectiveness of the system to Microbiology Division Q&RA leadership.
• Analyze trends and collaborates with manufacturing to investigate trends, conduct root cause analysis and lead corrective actions for processes and products.

How will you get here?

Minimum Education and Experience Requirements

• Bachelor’s Degree in a science, engineering or related field.
• 4 years of experience in a regulated environment such as medical device, biotechnology, or clinical.

Knowledge, Skills, Abilities

• Medical device, GMP, EU Regulation or ISO 13485 background
• Experience supporting medical device software and servicing preferred.
• ASQ certification preferred.
• Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), DOE (Design of Experiments) and Six Sigma.
• Demonstrated working knowledge of quality and scientific principles.
• Must be a self-starter who can take general concepts and direction and produce desirable results.
• Ability to prioritize multiple tasks to function effectively in a global, multi-site organization.
• Demonstrated ability to work effectively as a member of a cross-functional team.
• Strong working knowledge of various computer software for data analysis, such as Power Bi, Mini-tab, etc.
• Experience with lean manufacturing practices. Green Belt or Black Belt certification a plus.
• Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems.
• Excellent oral and written communication skills.
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.