Quality Assurance and Document Control Specialist
- Job Title
- Quality Assurance and Document Control Specialist
- Job ID
- 27647856
- Location
- Somerville, MA 02144
- Other Location
- Description
-
About Podimetrics:
Founded in 2011 by a physician and engineers from MIT and Harvard, Podimetrics set out on a
mission to improve patient lives through early detection and prevention of diabetic foot ulcers, the
leading cause of lower limb amputations. Podimetrics has since evolved to become a rapidly
growing virtual care management company with advanced technology and patient-centered
services.
Today, Podimetrics teams with and provides solutions to patients, payers and providers that
alleviate the health and financial implications of diabetic foot complications in high-risk
populations. We are a mission driven, financially responsible enterprise that enables patients to
stand on their own feet and live more independent and fulfilling lives.
Core Values:
● People First: We care for our people: team, patients, clinicians & health plans, and
stockholders.
● Efficacy Through Diversity: We commit to fostering an inclusive work environment where
ideas come from people of all backgrounds, gender identification, and race to best meet the
diverse needs of those we serve.
● Empathy & Compassion: We seek to understand and take action to improve.
● Respectful Candor: We are direct in communication and work to create an environment
where all can share their perspectives without risk of repercussions.
● Active Curiosity: We are deeply curious, always striving to learn more and do better.
● Resourcefulness: We are deliberate in our investment of team and capital, creating
opportunity regardless of resources.
● Do the Right Thing: We do the right thing, consistent with our values, even when it is
challenging.
● Enjoy the Ride: We are going to have a lot of fun doing it.
ABOUT THE ROLE
The Podimetrics Quality and Regulatory department is excited to add an experienced, collaborative,
and highly organized team member to support our growing operations and customer base. The
Quality Assurance and Documentation Specialist is expected to have an affinity for detail-oriented work,
prior experience working within a medical device company and good working knowledge of 21 CFR
820, ISO 13485, and electronic quality management systems. This role will work with the
Quality/Regulatory Manager to maintain compliance, establish sustainable quality system processes
to support manufacturing and device operations, and collaborate with various teams to ensure
the highest quality of Foot Monitoring Products and Services.
KEY RESPONSIBILITIES- Act as a Document Controller for the Quality System and manage engineering/manufacturing change requests. Ensure all change requests and corresponding documents are complete.
- Review, update and release quality system documents and records as needed in a timely manner.
- Maintain, store, and distribute electronic and hard copied controlled documents.
- Support CAPA and NCR root cause investigation, corrective action planning, and verification of effectiveness.
- Assist with complaint handling and adverse evening reporting process.
- Participate in and support FDA and ISO audits by running back-room audit activities.
- Own maintenance and improvements to Quality Management Software.
- Develop trend reports for various quality system operations for corrective actions and continuous improvement.
- Support R&D and engineering teams with documentation of verification and validation activities.
- Maintain internal training records and assist Quality & Regulatory Manager in running training programs.
- Help evaluate and manage supplier quality programs.
EDUCATION & EXPERIENCE- Minimum of a bachelor’s degree (BA or BS), preferably in Science, Engineering, or Regulatory/Quality affairs.
- Minimum of 5 years of experience within the Medical Device industry dealing with quality assurance and/or document control.
- Knowledge and experience in review of technical documents.
- Experience working with an electronic Quality Management System.
- Good practical knowledge of FDA 820 and ISO 13485 requirements.
- Experience in supporting and participating in FDA and ISO audits.
- Good working knowledge of Microsoft Office & Google G Suite.
CRITICAL COMPETENCIES
Attention to Detail: High attention to detail and a meticulous and organized approach to
documentation review.
Critical Thinking: Demonstrates analytic and problem-solving skills and understands the impact of
individual decisions on other parts of the organization.
Communication skills: Excellent written and verbal communication skills. Ability to present data
and articulate ideas in front of an audience.
Interpersonal skills: Establishes rapport quickly. Builds and maintains diverse relationships.
Teamwork: Respects colleagues and works well within and across teams. Motivates team members
to achieve high performance through collaboration and fellowship.
Adaptability: Embraces and adjusts quickly to change. Ability to work and thrive in a fast-paced
environment.
Resourcefulness: Finds creative solutions to difficult problems; doing a lot with a little.
Podimetrics is committed to a diverse and inclusive workplace. We are an equal opportunity
employer and do not discriminate on the basis of race, national origin, gender, gender identity,
sexual orientation, protected veteran status, disability, age, or other legally protected status.