Sr. Post Market QA Specialist

Job purpose

The purpose of the Sr. Post Market QA Specialist is to drive all complaint handling and vigilance reporting activities to ensure compliance to all internal procedures and global regulatory requirements. Additionally, this role will assist the Director, Post Market QA to provide support for complaint data research requests. This role will act as a subject matter expert (SME) for Post-Market Complaint Data. This role will also represent the complaints team on cross-functional teams for product and process improvement.

Duties and responsibilities

• Document the evaluation, categorization, evaluation, investigation and resolution of customer complaints to ensure compliance to GDP, internal procedures and global regulatory requirements, e.g., FDA, EU MDR, MEDDEV, ISO, etc.
• Make decisions related to global regulatory reporting ensuring compliance to all applicable regulations, guidelines and guidances and in accordance with internal procedures.
• Submit all required regulatory reports to global regulatory authorities ensuring compliance to all applicable regulations, guidelines and guidances and in accordance with internal procedures.
• Participate in and support internal and external audits.
• Author procedures, work instructions, forms, reports and letter templates to standardize departmental processes.
• Lead and support Continuous Process Improvement projects
• Provide training to Endotronix employees regarding the importance and regulatory requirements for complaint handling and global regulatory reporting.
• Monitoring and drive team priorities, goals and monthly KPIs.
• Support other Quality efforts, e.g. NCs, CAPAs, escalations, corrections & removals, as needed.
• Assist and support other employees, teams, and sales personnel as necessary
• Embody Endotronix's Core Values in all actions.

Qualifications

• 6+ years complaint handling and world-wide vigilance reporting experience in medical device/pharma, or other FDA regulated environment required. Experience with Class III devices preferred.
• Knowledge of FDA, ISO, and EU MDR quality management system regulations required.
• Experience and expertise in completing US MDR (3500A) form, EU MDR MIR Form required.
• Understanding of Good Documentation Practice.
• Able to work independently with minimal oversight.
• Strong written and verbal communication skills.
• Able to work in a dynamic and quickly changing environment.
• Comfortable taking on responsibilities as needed.

Education

• Bachelor's degree (preferred) OR completion of a college program with required qualifications listed above.

Key Leadership & Behavioral Competencies

• Business Acumen - Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
• Problem Solving - Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.
• Dealing with Ambiguity - Can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty.
• Strategic Agility - Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
• Managing Through Systems - Can design practices, processes, and procedures which allow managing from a distance; is comfortable letting things manage themselves without intervening; can make things work through others without being there; can impact people and results remotely.
• Drive for Results - Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results.
• Customer Focus - Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Innovation and Continuous Improvement - Commitment to continuous learning and implementation of better methods, tools and practices to increase customer employee and stockholder satisfaction.A clear understanding of gaps in the organization learned through facts or data gathered & analyzed followed by a clear action plan to reduce the gaps through learning and training. By constantly striving to innovate and improve processes by reducing "waste or Noise" in the system, we believe we will have the ability to stay ahead of our competition in the marketplace.
• Operate within Ethical, Moral, & Regulatory Standards -Continuously demonstrates in actions and speech the highest level of commitment to honesty, transparency, and ethical behavior and compliance with all applicable laws and regulations

Personal Characteristics

• Willing to have the "direct and honest conversation". Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
• Competitive spirit and drive to win. Strong sense of initiative, internal motivation and an unrelenting focus on results.
• Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
• Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
• Entrepreneurial, flexible, yet results-focused.
• High degree of intellectual curiosity, honesty and capability.
• Low ego and humble in spirit in spite of his/her track record of outstanding performance.

Position Type / Expected Hours of Work

Full Time (REMOTE). Salary Exempt

Working conditions

This job operates in a professional office environment. This role routinely uses standard office equipment.

Physical Requirements

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

EEO Statement

Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability.

Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors. This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.

This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination.

Executive, management and supervisory levels have the responsibility to further the implementation of this policy and ensure conformance by subordinates.

Individuals who feel they are the target of discrimination are encouraged to discuss the matter with their supervisor, another member of management or someone in the Human Resources Department.

Retaliation against claimants will not be tolerated.