Command Medical Products, Inc

COMMAND MEDICAL PRODUCTS, INC.

Job Description

JOB TITLE: Quality Engineer/Auditor

REPORTS TO: QARA Manager

CLASSIFICATION: Exempt

STATUS: Full-time

WC Class Code: 8810

DEPARTMENT: 700

GENERAL DESCRIPTION:

Quality Engineer: Assists in operational and engineering activities to ensure that the quality of the product and the services are achieved, maintained, and improved.

Internal/External Auditor: Ensures internal compliance to the Quality System GMPs, Process Capabilities and governmental regulations such as FDA and ISO13485 standards and requirements as appropriate. Performs Supplier Audits to determine the state of the Quality Systems, GMPs and Process Capabilities in support of ongoing business and new product introductions, to ensure that supplier systems are aligned with current regulatory requirements, standards, industry trends, and client policies and standards.

ESSENTIAL FUNCTIONS:

Quality Engineer

·  Assists with the Complaint system and Corrective and Preventative Action (CAPA) system

·  Collects and analyzes quality metrics

·  Assists with process validation; process capabilities; and process improvements.

·  Provides Statistical Process Control (SPC) support

·  Conducts failure and reliability testing, and root cause analysis as a result of complaints, non-conforming material and product, etc.

·  Reviews and approves proposed manufacturing and specification changes.

·  Exercises considerable judgment to define manufacturing requirements and processes using LEAN MANUFACTURING concepts.

·  Analyzes product, customer, and regulatory requirements to determine tools, fixtures and equipment requirements for assigned projects.

·  Reviews current processes and procedures against actual practices and update/improve processes and procedures.

·  Attends and participates in a variety of meetings and task force groups to integrate activities, and communicate issues, obtain approvals, resolve problems and maintain a specific level of knowledge pertaining to new developments, requirements, and policies.

Internal/External Auditor

·  Ensures compliance with established internal control procedures by examining records, reports, operating practices, and documentation.

·  Develops/monitors process performance metrics specific to the overall quality system

·  Completes audit work-papers by documenting audit findings.

·  Appraises adequacy of internal control systems by completing audit questionnaires and checklists.

·  Maintains internal control systems by updating audit programs and questionnaires; recommending new policies and procedures.

·  Communicates audit findings by preparing a final report; discussing findings with auditees.

·  Complies with FDA/ISO requirements; enforces adherence to requirements; advises management on actions.

·  Prepares audit and control reports by collecting, analyzing, and summarizing operating information and trends.

·  Contributes to team effort by accomplishing related results as needed

·  Receives and analyzes critical supplier's details and assesses compliance to quality and performance standards

·  Audits the critical suppliers that best meet the quality requirements and product specifications

·  Ensures the supplier is providing quality goods in necessary quantities as specified in contracts

·  Monitors the supplier's performance and verify if they confer to all contractual regulations

·  Drive continuous improvement while ensuring compliance to applicable regulations

·  Assists the quality team in performing product performance testing, as needed

MINIMUM QUALIFICATIONS:

·  Must have a Bachelors Degree and previous experience with Medical Device Quality Engineering.

·  ASQ, CQE, & Quality Auditor Certification (or in process of obtaining) preferred.

·  Understanding of Statistical Process Control (SPC) charts and control charting concepts preferred.

·  Experience with quality trending analysis and reporting

·  In-depth knowledge of Supplier Quality Management principles, expert auditing and problem solving skills, in-depth knowledge of Quality and operations systems and processes.

·  Demonstrated ability to translate GMP requirements into SOPs and specifications, understanding of GMPs as they pertain to manufacturing, testing and packaging of drug or medical products.

·  Demonstrated ability to identify compliance risks and assess business impact.

·  Experience performing inspections of supplier companies in the medical device industry.

·  Knowledge of ISO 13485, and FDA’s 21 CFR 820, Medical Device Directive,, and medical device regulations.

·  Experience interacting with suppliers to obtain information and building the supplier-customer relationship.

·  Experience writing accurate, complete, fact-based audit reports, citing regulations to illustrate the point.

·  Experience with a vendor management program would be considered a plus

WORKING CONDITIONS:

Varying from a good working conditions in office environment with regular exposure to manufacturing areas to somewhat undesirable working conditions with exposure to fumes, noise, grease and dirt, with no element continuously present to the extent of being disagreeable. Must be able to travel within and outside the United States.

SELECTION GUIDELINES

Formal application, rating of education and experience, oral interview, reference check and job related tests may be required. The duties listed above are intended only as illustration of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to a position. The job description does not constitute an employment agreement between the employer and employee, does not state or imply that these are the only duties to be performed by this employee and is subject to change by the employer as the needs of the employer and requirements of the job change. Reasonable accommodations will be made for otherwise qualified individuals with a disability.

I have read the above job description and I understand that additional functions may be required and may not be limited to the ones already stated in this document. I am able to perform the essential functions of the job for Quality Engineer job description. I understand that working hours are subject to change according to company needs.

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Employee Signature Date

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Human Resources Signature Date

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