Quality Assurance Director |
| Nov. 02, 2009 - Dec. 02, 2009 |
| Location: | Reno, NV |
| Salary Range: | 75,000 - 100,000 |
| Exempt/Non-Exempt: | Exempt |
| Benefits: | Health, 401k w/ 3% match, generous PTO, tuition reimbursement |
| Employment Type: | Full Time |
| Department: | Quality Assurance |
| Description: | I. PURPOSE OF JOB
This position is responsible for the development, implementation, administration, and improvement of all quality system processes. The Director, Quality Assurance, will ensure the Company’s adherence to the Regulatory Standard and Code of Federal Regulations, both foreign and domestic, as they relate to Company operations and product compliance.
II.SCOPE
Under minimal supervision, this position reports to the Vice President of Innovation and has the following direct reports: Quality Specialist and Quality Coordinator. This position is responsible for developing and maintaining quality systems that support BSSI’s vision and mission.
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| Duties: | III. PRINCIPAL DUTIES AND RESPONSIBILITIES
•It is the responsibility of the Director, Quality Assurance, to ensure that the policies set forth in the Quality Policy and Manual are communicated to all Team Members of BSSI team.
•Support the creation of the company’s Quality vision and roadmap. Implement, maintain, monitor and verify the effectiveness of the Quality System.
•Determine and provide the needed resources, including the assignment of qualified personnel for all activities performed by the Quality Assurance Department including, but not limited to, internal auditing, Product Inspection (domestic and overseas), complaint management, and trending/analysis & reporting.
•Review and approve Standard Operating Procedures (SOPs). Initiate new SOPs when appropriate. Manage the SOP process and adherence to current SOPs.
•Chair the Material Review Boards for review of nonconforming product.
•Chair the ISO/Semi-Annual Management Review Committee designated for the review of Quality System implementation and effectiveness.
•Identify mandatory Quality Records that must be maintained to demonstrate compliance to the Quality System Standard Operating Procedures.
•Identify those positions within the Company that are required to have job descriptions due to their impact on, or responsibility for Quality System functions.
•Provide final authority for the release or rejection of product following Certificate of Analysis review or product testing.
•Review, approve and verify all Internal Corrective/Preventive Actions and Factory Corrective Preventive Actions.
•Develop the yearly annual audit schedule and performance of internal audits.
•Perform presentations on the Corporate Quality System and train personnel on Quality Systems. Develop and maintain performance metrics for the Quality Assurance Department as well as individual incumbents to ensure measurable performance.
•Develop annual departmental budget.
•Design of company metrics for the Quality Assurance department and other disciplines as requested.
•Reporting, as requested to senior members of management; product quality, service quality, and all other metrics requested.
•Manage the creation and maintenance of Product Specifications and Technical Files.
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| Qualifications: | IV. KNOWLEDGE, SKILLS, AND ABILITIES
Education:
•BS degree in an applicable discipline or equivalent work experience in the Quality Assurance field is required.
Experience:
•Minimum 3 years experience in the pharmaceutical, medical device or related industries.
•Minimum 5 years experience working with and/or managing quality assurance and quality control systems.
•ASQ Certification as a Quality Auditor, or ISO 13485/ISO 9000 Lead Auditor training
Skills:
•Excellent understanding of FDA Quality System Requirements, ISO 13485/ISO 9000 standards and the European Medical Device Directive.
•Computer literate in Microsoft Office, Microsoft Word, Microsoft Project, Microsoft Visio and Excel software applications.
•Strong understanding of quality control practices in high-volume manufacturing environment
•Excellent written and oral communication skills.
•Strong organizational skills.
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