Job Description

Job Summary

Responsible for providing technical leadership for all aspects of quality control program to ensure continuous production of products consistent with established standards. Monitors and analyzes statistical data and product specifications to determine conformance of incoming raw materials, subassemblies, and finished products to established company requirements and specifications, and applicable industry standards. Handles multiple projects from product inception and development, through manufacture and customer use. Responsible for supporting all activities including but not limited to design control activities, process validations, inspection and test, and equipment maintenance and calibration.

Duties & Responsibilities

• Generate, update, and/or review process documents for release via the change order process and ensure that the inspection procedures are up to date.
• Lead and participate in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues.
• Lead and participate in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies, and risk management activities to assure conformance to product quality standards and applicable regulations.
• Monitor and control the Non-Conformance process and participates in the MRB activities.
• Organize and manage the Quality Control Records.
• Ensure that adequate inspection equipment is available, maintained, and calibrated.
• Provide support for internal and external audits and formulates response to audit findings and CAPAs.
• Prepare and report QC metrics at QMS reviews.
• Support the maintenance & calibration coordination program and activities.
• Perform other duties and special projects as requested.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Two or more years of experience with quality control process for inspection and testing of electronic components, subassemblies, and finished products or equivalent.
• Hands on experience implementing and using statistical methods throughout various aspects of product realization, e.g., PFMEA, DFMEA, DOE and GR&R methodologies.
• Knowledge and experience working within a Quality Management System (QMS) in a regulated industry.
• Knowledge of equipment calibration process and associated regulatory requirements.
• Excellent computer skills in Microsoft Office suite.
• Excellent written and communication skills.
• Good interpersonal skills dealing with peers and other functional areas.
• Ability to travel locally, domestically, and internationally, as needed.
• Ability to work independently with minimum supervision.

Preferred Qualifications

• Prior experience in a Medical Device manufacturing environment.
• Knowledge and experience with IPC 610, 620, IPC J-STD-001E, and MIL-T-31000/MIL-STD-100E. 
• Familiar with Part 820 Quality Systems Regulation.
• Familiar with ISO-13485 requirements.
• Proficient in utilizing Minitab for statistical data analysis.                                                                                          
   

Education

Bachelor’s degree in engineering, manufacturing, or quality is required.

Compensation: The anticipated range for this position is $61,000 - $91,000.  Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical requirements/Work Environment

This position primarily works in an office, laboratory, and manufacturing environment. It requires frequent sitting, standing and walking.  Daily use of a computer and other computing and digital/mechanical devices is required.  May sit or stand for extended periods.  Must be able to regularly lift up to 35 pounds.  Local, domestic, and international travel up to 20% of the time may be necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.