Director of Quality - (US-AZ-Apache Junction - 85290)

Compensation: $100K - $110K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: 3154
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Our client is a clinical supply company based in Phoenix, Arizona. They focus on supplying the global clinical world with products that improve health care. Their products range from surgical materials, needles, personal care items to lab products and uniforms. Our client boasts two distribution warehouses in Phoenix that handle products arriving daily from their manufacturing facilities located both in the U.S. and on the Pacific Rim. They strongly believe in creating a working environment for people with a drive for success, an entrepreneurial spirit and a family-oriented nature. They have many programs that reward employees for their dedication and contributions. This is an excellent opportunity for the right candidate.

Job Responsibilities:
1) Serve as a management representative
2) Establish, implement, and maintain the quality system
3) Prepare reports for the management review meetings
4) Provide and analyze quality metrics to the organization
5) Establish, implement and maintain the Quality Plan for the company
6) Provide for quality system consulting to functional areas
7) Participate in change and problem-solving teams and as an agent for compliant change
8) Implement quality management strategy/assist in setting policy/setting quality goals and milestones
9) Interpret day-to-day regulations and company procedures and policies
10) Supervise and manage the CAPA Program
11) Work with functional areas to establish/maintain batch records, device master files
12) Oversee suppliers’ quality (evaluation and certification of suppliers)
13) Prepare medical Device Reports (MDRs) and Vigilance Reports (Europe)
14) Implement and maintain a Quality Auditing Program
15) Coordinate and conduct internal audits
16) Host external audits – customers, regulatory agencies, business partners
17) Implement and maintain a Quality Training Program
18) Oversee training policies and training requirements for the organization
19) Work with functional areas to establish procedures and integrated program plans in preparing FDA, state pharmaceutical inspectors or third party audits
20) Undertake risk analysis and management program
21) Support manufacturing, design control, qualification/validation of equipment and process validation
22) Prepare FDA 510(k) and technical files
23) Oversee FDA compliant document management system

Job Requirements:
1) Minimum 3 years of experience in medical device, biologic or drug manufacturing as a Certified Quality Auditor (CQA)/Certified Quality Manager (CQM), or Director of Regulatory Affairs
2) Experience as a Quality Assurance RA Director in an FDA-regulated environment with CE Marking and the medical device expertise
3) Experience in ensuring compliance with US FDA, EU EMEA, etc.
4) Multitasking and project management skills
5) Professional behavior with both internal/external business associates consistent with the company’s policies and practices
6) Strong communication (written and verbal) skills
7) Excellent knowledge of cGMPs, GCP, GLP, ICH guidelines and ISO standards
8) Detail-oriented and well-organized
9) Ability to work independently and in teams
10) Ability to work at a keyboard for extended periods

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03154.html