Post Market Surveillance Specialist

Position Summary

Responsible for receiving, reviewing, and processing product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy. This position combines skills in post market regulation, statistics, and product knowledge in the process of trending and handling incoming complaints. Partners with Product Support / Quality Engineering or other investigators on product investigations and trends. The Specialist 1 is provided direction from the Post Market Surveillance Manager to maintain the complaint processes and is in process of acquiring the job skills to complete these tasks.

Foundations of Success:

The Post Market Surveillance Specialist 1 will exemplify the following principles:

Lead with Ownership - Demonstrate integrity and always aim to do the right thing. Be highly accountable for your work, follow through on commitments, and take responsibility when things don’t go as planned. Embrace opportunities to try new things and learn from mistakes.

Act with Speed - Approach tasks with a strong sense of urgency and a bias toward action. Keep stakeholders informed by providing regular updates early and often, ensuring transparency and avoiding unexpected surprises, even when working at a fast pace.

Foster Partnerships - Collaborate effectively with teammates and stakeholders to achieve shared goals. Invest in building strong working relationships and contribute to efforts that fulfill the organization’s Purpose, Promise, and Passion.

Delight Customers - Strive to exceed expectations by delivering high-quality work, exceptional experiences, and innovative solutions. Engage in proactive communication, provide excellent service, and develop a deep understanding of customer needs to create positive, lasting impressions and build trust-based relationships.

Celebrate WINS! - Take pride in delivering impactful results. Contribute to a positive team environment by celebrating both individual and team accomplishments. Support colleagues, recognize collective successes, and embody the mindset of an 'A-player' who inspires others.

Essential Duties and Responsibilities

The incumbent may be required to perform additional duties related to the functions listed below, as reasonably necessary to meet business needs, including but not limited to:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues, including fulfillment, assay and instrument complaints.
• Assists with the review of complaints to determine potential adverse events.
• Assists with the preparing and submitting post market surveillance reporting including but not limited to Medical Device Reports and Adverse Events to the FDA within regulatory timeframes.
• Assists with the writing and approving vigilance reports/international regulatory submissions.
• Assists with complex investigations as required.
• Conducts timely and insightful response to investigations.
• Assists with the department metrics and works with others to ensure department goals are achieved.
• Assists with preparing agendas, facilitates cross functional meetings and creates meeting minutes.
• Assists with owners on determination of effective CAPA.
• Work with Technical Service or Field Service to ensure appropriate required information is documented in complaint.
• Works with other Post Market Surveillance personnel to ensure consistency in documenting complaints.
• Assist in external & internal audits.
• Assists with the customer communication (response letters, acknowledgement letters) as appropriate.
• Performs queries to provide complaint data and trend analysis on reported product problems/complaints.
• Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
• Creates or update QMS documents.
• Other duties as assigned.

Excellence through Integrity, Compliance, Safety and Environment

• Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
• Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
• Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
• Engage in continuous improvement initiatives, striving for operational excellence and efficiency.
• Promote sustainable practices within the workplace, including waste reduction, recycling, and energy conservation.
• Participate as applicable in workshops, training sessions, and other activities aimed at fostering a culture of continuous improvement and lean thinking.
• Participate in regular training and complete all training on time.

Qualifications

Education

• Bachelor’s Degree required, preferably in a healthcare related field.

Experience

• Minimum 0 – 1 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations understanding of drug/device safety requirements are required.

Skills

• Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
• Prior experience processing medical device or drug complaints strongly preferred.
• Strong interpersonal skills.
• Knowledge based PC computer skills essential, such as industry recognized complaint management systems, MS Access and Excel.