Senior Quality & Validation Engineer {SE}

Summary

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.

âResponsible for all engineering aspects of the company quality function.
âReceives customer contacts by telephone fax letters and in person. Responds to all customersâ quality inquires; provides technical assistance to customerâs issues and determines and implements appropriate disposition.
âProvides technical assistance and training to production and manufacturing engineering personnel.
âParticipate in Contract Review process to assure that Engineering Master addresses all customer requirements as documented in supplier agreements procedures work instructions and engineering drawings.
âPrepares quality control plans and IMS sheets
âDefines inspection methods and selecting gauges appropriate for inspection activities.
âParticipates in corrective action including investigation root cause analysis corrective action and preventive actions.
âAssist with receiving first piece in process and final inspections for new products as required.
âResponsible for assuring that assigned activities are performed in accordance with Quality Management System.
âResponsible for creating and maintaining quality system documentation.
âRecommend new part verification technologies and if approved assist in implementation
âAs applicable understand and implement advanced Quality Software.
âCMM and Vision System Programming
âAs required perform cross functional task until appropriate resources are in place.

Qualifications

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.

âBroad knowledge of FDA Quality System Regulations and ISO 13485 standard.
âProficient with CMM surface plate technology shop math and mechanical inspection instruments and blueprints.
âStrong analytical skills and the ability to express technical concepts effectively both written and verbal.
âProficient at data collection analysis and presentation.
âExcellent computer skills and proficiency with MS Office and the internet.
âStrong communication skills and ability to work closely with external and internal customers.

Education and/or Experience

âBachelor degree or equivalent previous experience preferred

Language Skills

âAbility 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.

Reasoning Ability

âAbility 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.

Computer Skills

â Proficient in all Microsoft Office applications (Word Excel Outlook)

Physical Demands

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.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

ADDITIONAL NOTES

ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis.
This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments.

A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully the incumbent(s) will possess the skills aptitudes and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge skills or abilities.

Required Experience:

Senior IC