Introduction to Workwarp and the Medical Device Manufacturing Industry
Workwarp, a leading player in the medical device manufacturing sector, is seeking an experienced Quality System Integration Specialist - Contractor to join their team. The medical device industry is a rapidly evolving field, driven by innovation and a commitment to improving patient outcomes. As a Quality System Integration Specialist, you will play a critical role in ensuring that Workwarp's products meet the highest standards of quality, safety, and regulatory compliance. If you are passionate about quality assurance and have a strong background in FDA regulations and ISO standards, this could be an exciting opportunity for you to make a meaningful contribution to the industry.
Role Overview
In this role, you will be responsible for integrating and maintaining Quality Systems in compliance with FDA regulations and ISO standards. You will work closely with cross-functional teams to create, revise, and review Quality System documents, ensuring that all processes and procedures are aligned with regulatory requirements. Your expertise will be essential in supporting the migration of documents and records into electronic systems, as well as training staff on new procedures and ensuring completion of training. You will also maintain project schedules and trackers related to integration activities, ensuring that all projects are delivered on time and to the required standard.
Key Responsibilities:
- Integrate and maintain Quality Systems in compliance with FDA regulations and ISO standards, including 21 CFR Part 11 and ISO 13485
- Create, revise, and review Quality System documents, such as SOPs, work instructions, and quality manuals, to ensure regulatory compliance
- Support the migration of documents and records into electronic systems, such as document management systems and quality management software
- Assist in the training of staff on new procedures and ensure completion of training, including providing guidance on quality procedures and protocols
- Maintain project schedules and trackers related to integration activities, including project plans, timelines, and resource allocation
- Collaborate with cross-functional teams, including quality assurance, regulatory affairs, and operations, to ensure that all processes and procedures are aligned with regulatory requirements
- Stay up-to-date with changes in FDA regulations and ISO standards, and implement changes as necessary to ensure ongoing compliance
Essential Qualifications
To be successful in this role, you will need to have a strong educational foundation in life sciences or a related field, as well as a minimum of 5 years' experience in an FDA-regulated medical device environment. You will need to have a deep understanding of FDA regulations and ISO standards, including 21 CFR Part 11 and ISO 13485. Excellent verbal and written communication skills are essential, as you will be working closely with cross-functional teams and communicating complex information to stakeholders. You will also need to be able to work independently and collaboratively within a team, with a strong ability to prioritize tasks and manage multiple projects simultaneously.
Preferred Qualifications:
- Experience with electronic documentation and training systems, such as document management systems and learning management systems
- Familiarity with computer/quality system software management, including software validation and verification
- Knowledge of new product development documentation, including design controls and design history files
- Proficiency in Microsoft Office and technical document applications, such as Adobe Acrobat
- Awareness of EU regulations related to medical devices, including the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR)
Skills and Competencies
In addition to the essential and preferred qualifications, you will need to have a range of skills and competencies to be successful in this role. These include:
- Quality mindset: a strong focus on quality and a commitment to ensuring that all processes and procedures are aligned with regulatory requirements
- Attention to detail: a high level of attention to detail, with the ability to review and analyze complex documents and data
- Communication skills: excellent verbal and written communication skills, with the ability to communicate complex information to stakeholders
- Collaboration and teamwork: the ability to work closely with cross-functional teams, including quality assurance, regulatory affairs, and operations
- Problem-solving and analytical skills: strong problem-solving and analytical skills, with the ability to analyze complex data and develop creative solutions
Career Growth Opportunities and Learning Benefits
At Workwarp, we are committed to the growth and development of our employees. As a Quality System Integration Specialist - Contractor, you will have access to a range of training and development opportunities, including:
- Professional development: opportunities for professional development, including training and certification programs
- Mentorship: mentorship and coaching from experienced quality professionals
- Cross-functional training: opportunities for cross-functional training, including training in regulatory affairs, operations, and quality assurance
- Industry conferences and events: opportunities to attend industry conferences and events, including conferences on FDA regulations and ISO standards
Work Environment and Company Culture
At Workwarp, we are committed to creating a supportive and inclusive work environment that fosters collaboration, creativity, and innovation. Our company culture is built on a foundation of:
- Respect and inclusivity: a culture of respect and inclusivity, where all employees feel valued and supported
- Collaboration and teamwork: a strong focus on collaboration and teamwork, with opportunities for cross-functional training and development
- Wellness and diversity: a commitment to wellness and diversity, with programs and initiatives to support employee well-being and promote diversity and inclusion
- Recognition and reward: a culture of recognition and reward, where employees are recognized and rewarded for their contributions and achievements
Compensation, Perks, and Benefits
We offer a competitive salary of up to $50 per hour, as well as a comprehensive benefits package, including:
- Medical, dental, and vision coverage: comprehensive medical, dental, and vision coverage, with a range of plan options to suit your needs
- 401k matching and ESPP: 401k matching and employee stock purchase plan (ESPP), with opportunities to save for your future and invest in the company's success
- Flexible vacation time: flexible vacation time, with opportunities to take time off and recharge
- Recognition awards: recognition awards, including bonuses and other incentives, to recognize and reward your contributions and achievements
Conclusion
If you are a motivated and experienced quality professional, with a strong background in FDA regulations and ISO standards, we encourage you to apply for this exciting opportunity. As a Quality System Integration Specialist - Contractor at Workwarp, you will have the chance to make a meaningful contribution to the medical device manufacturing industry, while developing your skills and advancing your career. Don't hesitate to apply – submit your application today and take the first step towards a rewarding and challenging career with Workwarp!
Apply Now!
Don't worry if you don't meet every single requirement – we value a great attitude and a willingness to learn above all. Submit your application today and join our team of dedicated quality professionals!
Apply Now