Medical Device Quality Assurance Manager

EDGE BIOLOGICALS INC specializes in manufacturing freshly prepared culture media that can be specifically formulated to fit the microbiological testing needs of our customers in the clinical, pharmaceutical, environmental, water, food/beverage, cosmetic, and veterinary sectors.

We are currently looking for a Quality Assurance Manager to join our Quality Team. The successful candidate will be responsible for assuring that EDGE BIOLOGICALS INC’s products meet quality standards and customer requirements. The position will also be in charge of maintaining the Quality Management System in regards to FDA regulations. This person will need to possess strong organizational and interpersonal skills as well as the ability to problem solve. The ideal candidate will also be able to work independently with a strong sense of urgency.

Responsibilities:
Proactively monitor all incoming and outgoing material, processes, and products for accuracy

• Act as Management Representative for company’s quality system.
• Maintain quality manual, quality plan, quality procedures (SOPs), and quality forms.
• Develop and measure company’s quality objectives.
• Monitor company’s state of compliance to US FDA device regulations and standards.
• Review complaints, NCMRs and other quality data for need to perform root cause investigations.
• Collect and analyze sources of quality data for need to initiate corrective or preventive action.
• Open, assign, monitor, approve and close corrective and preventive actions (CAPAs).
• Review complaints for reportable events and file with appropriate regulatory bodies when reportable events are identified.
• Manage FDA and other regulatory body inspections
• Write responses to inspectional reports.
• Create and maintain risk management files.
• Update and maintain device master records (DMRs).
• Issue device history records (DHRs) and sign off completed DHRs to release finished product.
• Maintain employee training requirements and records.
• Run management reviews and manage action items generated from the reviews.
• Run internal audit program and manage corrective actions related to audit findings
• Approve labeling creation and changes.
• Perform health hazard evaluations, when needed.
• Initiate and release quality holds, when needed.
• Initiate and manage field actions, when needed.
• Manage incoming inspections.
• Monitor supplier quality.
• Implement process controls.
• Perform/oversee validations and verifications and process validations.
• Performs other duties as assigned.

QUALIFICATIONS:

• Bachelor's degree plus a minimum of 5 Years’ medical device quality system experience is required.
• 5 years of FDA regulated medical device QMS experience
• 3 Years of Managerial Role experience
• Computer experience with MS Office (e.g., Word, Excel, Outlook, etc.).
• Statistical techniques used for sampling plans, trending, etc.

Required Skills:
·Strong organizational skills with attention to detail and proven ability to meet deadlines.
·Excellent communication skills with proven ability to work with your team members.
·Strong interpersonal skills with proven ability to work with your team members.
·Ability to problem solve quickly and effectively under pressure.
·Strong time management skills with ability to meet deadlines.

Job Type: Full-time

Pay: $55,000.00 - $75,000.00 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 5 years (Required)
• GMP: 3 years (Required)
• Laboratory procedures: 5 years (Required)

Ability to Commute:

• Memphis, TN 38107 (Required)

Ability to Relocate:

• Memphis, TN 38107: Relocate before starting work (Preferred)

Work Location: In person

Salary : $55,000 - $75,000