This role will be responsible for all released non-biopharmaceutical product quality including, but not limited to, ongoing continuous improvement, managing customer feedback, and customer expectations. This role involves direct customer communication to resolve issues and complaints, manages applicable standard operating procedures associated with released product quality and leads cross-functional teams involving manufacturing and continuation engineering, tooling, etc.
Essential Job Responsibilities:
Leads a team of cross functional engineers and technicians to resolve customer complaints and partner with sales/marketing to address customer inquiries.
Authors and maintains quality policies for complaints and non-conformances.
Functional supervision of technicians for processing of non-conformances and complaints.
Partners with our supplier quality engineering team to resolve supplier-related issues.
Support of external audits including customer and ISO certification audits.
Develops and improves inspection plans/methods for new or existing processes.
Responsible for ECO review and follow-through for released products.
Manages internal failure-response systems such as RGAs and recalls.
Support efforts to evaluate, manage and improve measured Quality performance throughout CPC.
Work with customers and other CPC Engineers to ensure system-wide response to customer needs.
Serves as a resource for Continuous Improvement efforts throughout CPC.
Keeps current in the field with internal and external education and training.
Adheres to all safety regulations.
Demonstrates support of CPC core values.
Performs other job duties as assigned to meet business needs.
Essential Supervisory Responsibilities:
None Required Job Qualifications:
Bachelor's Degree in engineering or equivalent technical field.
Minimum 3 years' experience in quality, manufacturing or continuation engineering roles (1 year for master's degree).
Understanding of up to date quality theories, methods and approaches, including ISO9001:2015
Experience working with data and statistical analysis software.
Passion for improvement and drive for change to meet customer needs.
Experience with automation assembly processes.
Good communication skills.
Experience with problem solving tools.
Excel, Microsoft, statistical Software.
Preferred Job Qualifications:
Master's degree in engineering, business or equivalent field.
Experience in regulated work environments, pharmaceutical or medical device preferred.
Experience in molding and machining processes.
Experience with ISO13485:2016.
Detailed knowledge of CPC parts or equivalent.
ASQ participation and certification(s).
Physical Demands:
The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand, walk and/or stoop.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
