Senior Post-Market Complaint Handling Process Control Lead

Recruiter: Spencer Gregory Hale

Senior Post-Market Complaint Handling Process Control Lead

About the role:

The Quality Engineer in Post-Market Complaints is responsible for establishing and maintaining the process controls and quality metrics used to monitor the accuracy and integrity of the outputs from the complaint handling process. This role is critical for ensuring compliance with regulatory requirements, including those from the FDA and other global regulatory bodies, and for maintaining processes that are efficient and stable.

Key responsibilities include:

• Process monitoring and control: Establish robust process controls for complaint handling process outputs that remain aligned with customer requirements.  
• Data analysis and trending: Collect, analyze, and report to senior management on key process outputs related to complaint handling.
• Process improvement: Utilize expertise in quality control, statistical methods, and systems thinking to drive continuous improvement initiatives for the complaint handling process.
• Root cause analysis: Lead and participate in root cause investigations for recurring process failures, implementing effective corrective and preventive actions (CAPAs).
• Cross-functional collaboration: Work closely with the complaint handling team, Risk Management, and IT/Systems.
• Systems thinking and analysis: Evaluate the end-to-end complaint handling process, from intake to adverse event reporting, identifying and analyzing system-wide dependencies, bottlenecks, and potential failure modes to proactively mitigate risks.
• Technical Leadership: Lead a team of global and divisional subject matter experts responsible for the monitoring of the complaint handling process.
• Documentation and Standardization: Coordinate with global and divisional teams to create and maintain clear documentation, including Standard Operating Procedures (SOPs), work instructions, and control plans, to ensure consistency and compliance with medical device regulatory requirements.
• Define and establish process requirements based on customer needs: Take process outputs, such as complaint codes, and build process requirements that meet the needs of all downstream customers that use the outputs for analysis and decision making.

What we're looking for in you:

Minimum requirements:

• Bachelor's degree in Industrial Engineering, Statistics, or a related technical discipline.
• 5+ years of experience in a quality control related role within a regulated industry, preferably medical devices or pharma.
• Experience with statistical process control (SPC) and other statistical tools for quality data analysis, with emphasis on SPC for business processes.

Preferred qualifications:

• ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification.
• Familiarity with systems thinking principles and the ability to apply them to complex business processes.
• Working knowledge of relevant medical device regulations, such as euMDR, ISO13485 and ISO 14971.

Core competencies

• Exceptional attention to detail and a methodical approach to data analysis.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, including the ability to present complex data to diverse audiences.
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Proactive and accountable mindset with a focus on delivering solutions.

Requisition ID: 620797 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. 

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.