Provides statistical information for quality improvement by identifying testing methods and samples. Responsible for all engineering aspects of the company quality function.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
• Responsible for all engineering aspects of the company quality function.
• Receives customer contacts by telephone, fax, letters, and in person. Responds to all customers’ quality inquires; provides technical assistance to customer’s issues, and determines and implements appropriate disposition.
• Provides technical assistance and training to production and manufacturing engineering personnel.
• Participate in Contract Review process to assure that Engineering Master addresses all customer requirements as documented in supplier agreements, procedures, work instructions, and engineering drawings.
• Prepares quality control plans and IMS sheets
• Defines inspection methods and selecting gauges appropriate for inspection activities.
• Participates in corrective action including investigation, root cause analysis, corrective action, and preventive actions.
• Assist with receiving, first piece, in process, and final inspections for new products as required.
• Responsible for assuring that assigned activities are performed in accordance with Quality Management System.
• Responsible for creating and maintaining quality system documentation.
• Recommend new part verification technologies and if approved, assist in implementation
• As applicable, understand and implement advanced Quality Software.
• CMM and Vision System Programming
• As required, perform cross functional task until appropriate resources are in place.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Broad knowledge of FDA Quality System Regulations and ISO 13485 standard.
• Proficient with CMM, surface plate technology, shop math, and mechanical inspection instruments, and blueprints.
• Strong analytical skills and the ability to express technical concepts effectively, both written and verbal.
• Proficient at data collection, analysis, and presentation.
• Excellent computer skills and proficiency with MS Office and the internet.
• Strong communication skills and ability to work closely with external and internal customers.
Education and/or Experience
• Bachelor degree or equivalent, previous experience preferred
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Proficient in all Microsoft Office applications (Word, Excel, Outlook)
The physical demands described here 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. While performing the duties of this Job, the employee is occasionally required to stand; walk and sit. Specific vision abilities required by this job include ability to adjust focus. Lifting/carrying up to 30lbs.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
ALIGN PRECISIONPhiladelphia, PA
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