Compensation: $50 to $70 hourly, depending on qualifications
Employment Type: 1099 Contractor
Contract Duration: Initial contract is for 6 months, could be extended to 1 year
SDED Global's client is working to improve people’s lives by providing quality products and services to life science and healthcare professionals. The company has grown to manufacture and sell over 130 biomedical research products and services to customers worldwide, all under an ISO 13485 compliant quality system. They are currently looking for an internal auditor to analyze their audit program and to perform audits on their systems and write the reports. As well as, assess the Internal Auditor program to determine if there are gaps. There could be potential for other work.
- Analyze and perform audits on quality compliant systems. Including monitoring progress and completion, and document gathering.
- Prepare and compile documents and information for regulatory reports, regulatory filings, and other documents to ensure accuracy.
- Maintain the compliance audit program, including schedules, standards, processes, reports and tools in close collaboration with the Compliance Officer.
- Conducts routine and ad-hoc audits; identifies gaps that require corrective action plans; monitors corrective action plans and takes appropriate action based on findings.
- Assist the Compliance Officer in conducting risk assessments.
- Maintain designated compliance applications, ensuring that contents are updated accurately and on a timely basis. Participates in application implementations and upgrades.
- Basic knowledge of federal and state regulations and standards related to compliance in the life sciences.
- Intermediate analytical skills, including the ability to interpret and determine the impact of complex laws, regulations and other documents.
- Basic problem-solving and negotiation skills.
- Basic knowledge of audit, control and monitoring processes, and the ability to effectively implement and maintain them.
- Basic knowledge of compliance systems, processes and reporting.
- Strong interpersonal skills with the ability to establish and maintain effective working relationships with individuals at all level.
- Strong oral and written communication skills with the ability to communicate professionally, effectively and persuasively to diverse individuals and groups.
- Ability to effectively prioritize multiple tasks and meet agreed-on deadlines.
- Strong customer service skills.
- Intermediate skills in Word, Excel and PowerPoint.
- Ability to work independently and as part of a team.
- Ability to speak and be understood in English.
- Ability to handle confidential information with appropriate discretion
- Knowledge of ISO 13485.
- Knowledge of laws, regulations and standards applicable to biotech and genomics.
- Bachelors Degree in related field; and
- At least four years in a substantially similar position in a life science company; or
- Equivalent combination of education and experience.
SDED Global works with companies that need to be FDA compliant. We provide solutions in Audits, Compliance, Software Development, Training and Validation, We accomplish this by working with client systems and remediation for any components that may be at risk. Our experts take a risk-based approach, doing what's right to ensure our clients are compliant by making certain they understand what needs to be accomplished. Our growing business has over 23 years of experience in excellence.
No man, woman or child should EVER suffer as a result of an adulterated or failed medical device. At SDED Global, it is our passion to ensure that this statement is fulfilled. SDED Global is a Medical Device Compliance Consulting firm that drives clients to excellence ensuring safe and effective medical devices domestically and internationally.
The CEO has worked in the medical device industry for 24+ years. Her education in biochemistry, began at the bench in Research/Development and led to experience in many areas of the industry from Quality to Software Development and Validation. She became integrated in what it took to confirm that a product adhered to the standards and regulations for various submissions. She thrived in this area. It is not only the goal of SDED Global, but her personal mantra, to not only adhere to but surpass global regulations and standards.
At SDED Global, we evaluate Client needs and customize the required strategy and solution to provide high Quality Compliance Consulting that is Efficient, Innovative, Analytical, Deliverable and first to market. We offer the best customer experience and empower our clients with skill sets to maintain a defend-able product. We not only meet their immediate needs we teach and guide all throughout the processes. This approach allows us to demonstrate what is required to sustain their long-term goals.
Role: Internal Auditor to Audit Program and Perform Audits
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