Job Description
At Safe PPE USA Inc we are looking for Team Members who want to be a part of producing the highest quality medical devices and kits available in the US market.
We offer competitive compensation and benefits packages for our Team Members.
Position: Quality Assurance Manager – Medical Device Industry
The Quality Assurance Manager will be responsible for:
The QA Manager is directly responsible for site QA activities, supporting Medical Devices and Pharmaceutical product platforms including final approval on all cGMP documents.
The QA Manager is responsible for several key systems in support of ISO 13485 & 21 CFR Part 20 requirements, site nonconformance investigations and associated CAPA, risk assessment, document control and product release/disposition in coordination with the QRT Team.
The QA Manager works independently and collectively as part of an integrated team environment with extensive interaction with Manufacturing, Maintenance and Administrative departments. The QA Manager is also responsible for tracking training and reporting to management on the compliance status of the site.
LANGUAGE SKILLS: Required reading, writing and speaking fluently in English and preparing reports.
PHYSICAL DEMANDS: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers, to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Vision abilities required by this job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT: While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles. The employee is exposed to laboratory chemical reagents and microbial cultures. The noise level in the work environment is usually quiet to moderate; some activities require personal protective equipment, which is provided. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Job Requirements:
QA: Authorized as the final approver for batch release, validation and QMS System documentation,
QMS Management Representative for ISO's at site interacting with auditors, including the FDA. Maintains quality service by enforcing organization standards and providing guidance to the site.
Actively supports the quality and business requirements of the EMS and Quality Systems.
Regulatory: Participates in communication with customers and prospective customers on product implementation and regulatory notifications related to product quality.
Maintains site compliance requirements for FDA and other relevant agencies.
Responsible for oversight of Pharmacovigilance System.
Validation: Represents Quality for engineering and validation programs by reviewing and approving validation documents.
Purchasing: Uses the purchasing system to qualify vendors and perform audits.
ISXpress System: Directly responsible for the ISXpress System to change or add new document requirements; coaching personnel. Assigned as a Document Control Coordinator in the writing and revision of documents.
CIMP System: Directly responsible for the continuous improvement events and projects.
NCR System: Directly responsible for the nonconformance system through investigation and reporting of nonconformance for the site. Provides reports and communication bases on investigation findings.
Training: Directly responsible for training system oversight. Provides reports to manager in support of continued competency. Monitors employee progress and competency to promote continued employee growth.
Other duties as assigned
Qualifications:
Minimum Requirements: BS/MS or extensive equivalent experience with 10+ years in a pharmaceutical, medical device, or related facility.
Experience in ISO standard execution.
Performance Management, Coordination, Coaching, Developing Standards, Process Improvement, Decision Making, Strategic Planning, Quality Management, ISO Implementation.
Jon Type: Full-time
Pay: $80,000.00 - $85,000.00 per year
Benefits: 401(k) Dental insurance Health insurance Life insurance Paid time off and Referral program Vision insurance
Job Type: Full-time
Pay: $80,000.00 - $85,000.00 per year
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