Position Summary
Works with engineering, manufacturing, sales, and operations in providing professional quality guidance to assess, correct, and maintain the product and process quality using statistical tools, documented methods, and audits. Works in a team environment to develop and implement best practices with emphasis on defect prevention, reduction in variation and waste, and provide for continuous improvements in meeting all customer and internal requirements.
Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
-
Establish and/or improve product/process quality individually through team-based problem-solving efforts using industry best practice skills.
-
Participate in MRB activities and evaluate NCRs as required. Coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of the corrective actions.
-
Manage and write process validations including but not limited to Master validation plans, PFMEA documentation, OQ/PQ protocol and OQ/PQ reports, PPAPS, FAIR, etc.
-
Analyze data using industry accepted statistical methods through process validation and continuous improvement activities.
-
Review and manage internal and external change control including customer specifications.
-
Work with operations and ERP teams for new Route and BOM approvals through Cable Builder software.
-
Facilitate software validation plans and works with the applicable team members to draft case studies, test cases and validation reports to route to management for final approval.
-
Support customer complaints through root cause analysis using industry standard investigation methods.
-
Support internal, customer and registrar audits as needed.
Qualifications
-
Strong understanding ISO 13485:2016 Quality Management System (QMS) requirements along with basic knowledge of CFR part 820.
-
Ability to fully understand customer specifications and specified standards
-
Ability to follow guidelines that are common throughout the industry, maintain a constant focus on quality and accuracy, follow directions, and work with minimal supervision
-
Understanding of test methods and techniques
-
Experience working in an ISO 13485:2016 manufacturing environment
-
Experience working in an FDA CFR part 820 manufacturing environment
-
General knowledge / understanding of product and process capabilities and limitations
-
Strong analytical and statistical knowledge, familiarity with Minitab Statistical Software preferred
-
Strong knowledge and background in process and product validation
-
Knowledge and background in software validation activities
-
Experience working with ERP systems
-
Proficiency in using MS Office, Internet, and e-mail.
-
BS in Engineering, or related technical or scientific discipline
-
1-3 years’ experience in a medical device manufacturing environment
-
Exceptional written and oral communication skills
-
Good time management and workload prioritization
-
Strong interpersonal skills
-
Experience working in a fast-paced Manufacturing environment
-
CAPA (Corrective Action / Preventive Action) Experience
-
Six Sigma Training preferred
Supervisory Responsibility
This position is not responsible for the oversight or performance management of other employees.
Safety Expectations
-
Obey all safety rules, use caution in work activities, and continuously practice safe behaviors.
-
Immediately report unsafe conditions/behaviors and work-related injuries to site supervision.
Work Environment
Professional office environment requiring routine use of standard office equipment including, but not limited to, computers, phones, photocopiers, filing cabinets and fax machines. Employee will need to visit the production/manufacturing floor to speak with operators and engineers. While in the manufacturing area, may be exposed to fumes or airborne particles, moving mechanical parts and vibration. The noise level can be loud at times.
Physical Demand
-
Sitting for periods of time at a desk in office environment.
-
Digital dexterity and hand/eye coordination in operation of office equipment.
-
Working in manufacturing environment periodically to observe production.
-
Ability to effectively communicate with customers, vendors, and or other employees via phone or in person.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
An Affirmative Action / Equal Opportunity Employer
Proterial Cable America provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. As a Federal Contractor, we encourage priority referral of protected veterans under VEVRAA.
