Post-Market Surveillance Manager

#ChangeMakers 

 
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We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss. 
 
We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others 
 
We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude. 

#WeChangeDentistry every day. Be part of it.

Salary: $85,000 -$105,000 /Annually.  The final pay for this position will vary based on geographic location and candidate experience relative to what the company reasonably anticipates for this position.

Summary of Position

The Post-Market Surveillance Manager within the ClearCorrect, a Straumann Group company, is responsible for ensuring that the necessary processes associated with the Post Market Surveillance (PMS) of released medical products are implemented in accordance with applicable corporate policies and regulations.  In this role the PMS Manager manages the Complaint Handling, Vigilance, Field Safety Corrective Actions (FSCA), and related data analysis functions within the company.  The PMS Manager also assists, coordinates, and trains the relevant positions within the PMS organization. 

The PMS Manager communicates findings arising from PMS activities to the functions responsible for Risk Management and Clinical Data as appropriate, and coordinates with these functions to prepare a Post-Market Surveillance Report on a regular basis.

The Post-Market Surveillance Manager also supports the Product Safety Officer (PSO) regarding submission of reports to authorities in cases of Adverse Events or Field Safety Corrective Actions. This position is an on-stie position.

Essential Functions and Duties

• Assure the Post Market Surveillance processes of ClearCorrect comply with relevant legal and regulatory requirements.
• Complaint Management
  • Manage the Complaint Management process to assure compliance with corporate policies and regulatory requirements.
  • Manage the Complaint Management team to ensure that all objectives, duties, and responsibilities are fulfilled and aligned with the defined Quality Management Objectives and customer expectations.
  • Define procedures, training programs and requirements for Complaint Management while ensuring application of the procedures.
  • Capture and analysis of complaint metrics as input to other processes as defined.
• Adverse Event Reporting
  • Manage the Adverse Event Reporting process to assure compliance with corporate policies and regulatory requirements.
  • Defining procedures, training programs and requirements for adverse event reporting while ensuring application of the procedures.
  • Escalate potential adverse events to the Product Safety Officer (PSO) for assessment of reportability and potential need for field action (depending on qualifications, the PMS Manager may also serve as the PSO).
  • Assist PSO with conducting and coordinating Product Safety Board meetings per defined procedures.
  • Capture and analysis of adverse event metrics as input to other processes as defined.
• Corrections & Removals
  • Manage the correction & removal process (i.e., recalls) to assure compliance with corporate policies and regulatory requirements.
  • Defining procedures, training programs and requirements for corrections & removals (i.e., recalls) while ensuring application of the procedures.
  • Capture and analysis of recall metrics as input to other processes as defined.
• Periodic Post-Market Surveillance Reporting
  • Defining and implementing PMS Report schedule according to the PMS procedure.
  • Preparing the PMS Plans for the European Union (EU) with the cross-functional PMS team for approval and release.
  • Coordinate with Provider Services/Customer Care function to assure capture and utilization of customer feedback in the Post Market Surveillance process.
  • Creating the PMS Reports for the EU with the cross-functional PMS team for approval and release.
  • Create annual PMS reports as required for Canada, Thailand, and any other countries that may request periodic reports.
  • Support the Design & Development team by providing the necessary PMS input in a timely manner.
  • Provide appropriate input to management processes e.g., CAPA, Management Review.

Manager Responsibilities:

This position manages the following positions:

• Quality Complaint Analyst, Quality Complaint Analyst II, Quality Complaint Analyst III
• Manage and lead diverse teams from different cultural backgrounds
• Foster an inclusive work environment that respects and leverages cultural differences.
• Provide training and development programs to enhance cross-cultural competencies within the organization

Minimum Qualifications

• Bachelors degree in Engineering or Business or equivalent work and clinical experience.
• 3+ years of experience in medical product post-market surveillance, prior experience in quality control, quality assurance, medical device manufacturing experience or actual clinical experience

Preferred Qualifications

• Training in Quality Systems with knowledge and understanding of the PMS requirements as defined in ISO 13485, EU MDR REGULATION (EU) 2017/745, US 21 CFR parts 803, 806, and 820, and others
• The ability to utilize the basic quality tools including Root Cause Analysis, Fishbone analysis, SPCs, checklists, histograms, Pareto charts, scatter diagrams, process mapping and flow charts
• Collaborative and Critical solution driven thinker
• Trained and technically competent in entire section assigned
• Training development and execution
• Multiple products, lines, and/ or shifts experience
• Culture champion
• Excellent Communication 

Physical Attributes:

• Observe and hear warning signs and signals within all areas of the company
• Stand, walk and/or sit up to 10 hours a day with periodic breaks allowed (Standing can be up to 10 hours, Walking can be up to 10 hours, and Sitting can be up to 10 hours)
• Will be working in a fast-paced environment

Work Environment:

• Work is performed primarily in an office environment
• The employee may occasionally be exposed to dust
• The noise level in the work environment is usually quiet to moderate
• The employee must be able to work in a fast-paced, team environment

 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

Employment Type: Full Time 

Alternative Locations: United States : Round Rock (TX) 

Travel Percentage: 0 - 10% 

Requisition ID: 17513