Quality Assurance Manager/ Director

QA manager :

Responsibilities :
- Development and maintenance of quality programs systems, processes and procedures that ensure compliance with internal and external standards and guidelines.
- Preparing update quality documents such as SOPs, work instructions and forms.
- review and approve records and documents to ensure conformance with regulations and procedures.
- Drive continuous improvement of quality management systems including nonconformance evaluations, root cause analysis and implementation of corrective actions.
- Conduct internal audits to ensure compliance .
- Follow FDA quality system regulations, high standards and SOPs as established by Dunamis‘s policies, practices and procedures.
- Ensure that all recordkeeping and documentation is completed in a timely manner according to establish policies ,Practices and procedures.
- Perform other duties as required. Participate and work with design development and design engineering in the completion of product verification and validation
- Resolve quality issues.
- Support development of US FDA submission requirements. Support postmarket efforts.
- Assessed with internal and external audits of all corporate quality systems and demonstrate compliance to objective evidence.
- Supervise and train personnel on materials and finished goods as necessary.
- Provide day-to-day oversight of quality including – testing, inspection, environmental monitoring etc.
- Verify that all production procedures have been followed and record such as DMR, the HR, DHF are maintained and updated or FDA and customer needs.
- Responsible to create implement and improve quality systems and procedures. Ensure the QMS and design quality requirements or effectively establish and maintained in accordance with the medical device regulations and international standards
- Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
- Assist with regulatory submissions including 510(k) premarket notifications for US FDA.
- Prepares regulatory submissions including technical files/design dossiers for registration of products as needed with Notified bodies
- Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.
- Assists with post market surveillance evaluation, trending, and reporting including updates to risk management (FMEA) process.
- Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites literature, trade sheets, competitor information, etc.).
- Maintains FDA establishment listings and registration.
- Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to medical devices including, 510(k)s, labeling and promotional materials, MDD 93/42/EEC, 21 CFR 820, global registration, technical writing, and external standards.
- Vendor sourcing and qualification .
- Other duties as assigned
- Must be present to lead FDA audits ,strategic or notified body audits .

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485
• Must be detail oriented
• Must possess strong interpersonal communication, teamwork and organizational skills. EDUCATION and/or EXPERIENCE Must have a bachelor’s degree from four-year College or university in a life sciences or engineering field.

. A minimum of 7 years in an FDA-regulated environment with QA/Quality design engineering .

• Minimum of 3 years of experience in medical device industry

. Bachelor’s Degree or equivalent is required. Desired experience in quality engineering

Job Type: Full-time

Pay: $79,184.65 - $125,000.00 per year

Schedule:

• Monday to Friday

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance medical device: 5 years (Required)

Willingness to travel:

• 50% (Preferred)

Work Location: Hybrid remote in Greenville, AL 36037

Salary : $79,185 - $125,000