The Quality Assurance Specialist II role involves implementing, maintaining, and auditing Quality Management System processes and corresponding records. Quality Assurance Specialists keep up to date with the requirements of the industry and develop a deep understanding of company processes to build a robust and efficient QMS to support the business.
What You Will Do:
- Assist with documentation and developing internal processes on how we handle feedback from users including customer complaints, product installs, and product release cycles.
- Drive change through Corrective and Preventive Action (CAPA) management.
- Participate in design projects and ensure design control procedural deliverable requirements are met. Support the design control lifecycle for existing and new product introduction.
- Meet existing regulatory requirements, keeping up to date of regulatory changes to ensure MIM Software and our teams are in regulatory compliance.
- Develop and maintain knowledge of MIM’s Markets and Primary Products and classifications, including knowledge of larger features within the software and secondary products.
- Organize and lead projects with stakeholders from various teams within the MIM.
- Support teams in planning, preparation, review and approval of quality documentation. Responsible for maintaining accurate records and files in our Quality Management System (QMS).
- Assist with audits by promptly delivering complete and accurate records. Proactively support future audit requests by keeping our QMS up to date so documents are easily accessible.
- Continuously monitor processes and procedures looking for efficiencies and enhancements.
- Continue to advance your skills by keeping up to date with the requirements of the industry.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
What You’ll Need:
- Bachelor’s degree in Engineering, Life Sciences or a related field is preferred
- 5+ years of related professional experience, preferably in software or the medical device field
- Must be highly organized, possess strong written and verbal communication skills, and have the ability to multitask.
- Ability to communicate effectively amongst all levels of the organization
What You'll Get:
- Hybrid work environment so you can work remotely as well as enjoy the office
- MIM pays 100% of your insurance monthly costs; including medical, dental, vision, disability, and life insurance
- Each employee received a Health Savings Account (HSA) that fully covers the medical deductible
- 20 vacation days and 11 paid company holidays, including the time between Christmas and New Years
- A 401(k) with a 4% match that is 100% vested on day one
- Annual Bonus Program
- Up to $8,000 in continued education costs annually
- Relaxed office setting where jeans are the norm
- Free snacks and beverages at the office
- 24 hour access to an in-office fitness center
WAIT, WHAT DOES MIM DO?
MIM provides medical imaging software to imaging centers, hospitals, specialty clinics, research organizations, and pharmaceutical companies across the globe. Our mission is to enhance patient care by providing tools to support the diagnostic and treatment process so the physician can focus on the patient.
Diversity Equity and Inclusion
MIM is committed to fostering a diverse and inclusive culture where everyone can contribute and thrive. We'll encourage, support, and learn from each other’s perspectives. This is both the right thing to do and vital: diverse perspectives fuel innovations that enhance patient care.
