Job Title: Document Control Specialist

Location: Hybrid - MA

Reports to: Quality Assurance and Document Control Specialist

Department: Quality and Regulatory

Key Relationships: All Departments

About Podimetrics: 

Founded in 2011, 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.
• 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 & Regulatory department is excited to add a collaborative and highly organized team member to support our growing operations and customer base. The Document Control Specialist is expected to have an affinity for detail-oriented work, excellent communication skills, and knowledge of medical device regulations such as 21 CFR 820 and ISO 13485. This role will work with the Quality and Regulatory team to maintain compliance, establish sustainable quality system processes to support manufacturing and device operations, and collaborate with various teams to ensure highest quality of Foot Monitoring Products and Services.

KEY RESPONSIBILITIES

• Act as a Document Controller for the Quality System and manage change requests. Ensure all change requests and corresponding documents are organized, complete, and maintained per Good Documentation Practices.
• Establish and manage proper document review processes per internal processes and external standards and regulations.
• Provide guidance to and collaborate with internal stakeholders on the document and change control process.
• Act as system administrator, ensuring that the Document Control system access and operation are maintained.
• Support Internal and External FDA and ISO audits by providing and tracking records from the Quality System
• Maintain and present trend reports for various quality system operations for corrective actions and continuous improvement.
• Support documentation of verification and validation activities for both quality and product systems.
• Maintain internal training records, assist in running training programs, and provide guidance to employees and managers on training requirements.

EDUCATION & EXPERIENCE

• Education: Minimum of a bachelor’s degree or equivalent experience
• Minimum of 5 years’ experience with Quality Management System, Document Control and Change Control, in a medical device industry
• Knowledge of 21 CFR 820 and ISO 13485 requirements.
• Proficiency with Microsoft Office & Google G Suite applications.
• Must be able to work independently with minimal supervision and in a team-oriented environment

CRTITICAL 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

Benefits: 

• Pay Range - $70,000 commensurate with experience
• Flexible Paid Time Off
• 16 weeks of paid parental leave.
• Competitive Medical, Dental, and Vision plans – Podimetrics covers 80% of premiums.
• Health Savings Account.
• Health Reimbursement Account.
• Employee Assistance Program - Free, confidential advice for team members who need help with stress, anxiety, financial planning, and legal issues.
• 401k; match up to 4%.
• Life Insurance - Podimetrics pays 100% of the cost of Basic Life & Personal Accident 
• Disability insurance – Podimetrics pays 100% of the cost of Short-Term and Long-Term Disability Insurance.
• Additional life insurance, critical illness, and accident coverage available.

Podimetrics is committed to a diverse and inclusive workplace. We are an equal opportunity employer and do not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.