Clinical QA Specialist

Lensa; Marlborough (MA); On-site; USD 83,000 - 130,000; Full time

Job summary

A leading company in the medical device industry seeks a Clinical QA Specialist in Marlborough, MA. This role focuses on ensuring quality compliance through thorough investigation of regulatory reports and fostering communication across various teams. Ideal candidates will have significant experience in quality assurance and a commitment to patient safety.

Qualifications

• Minimum 5 years’ experience in post-market surveillance and regulatory compliance.
• Hands-on experience with cross-functional teams.
• Track record of participation in audits and regulatory interactions.

Responsibilities

• Investigate and report on Potential Adverse Events and regulatory complaints.
• Collaborate with Technical Service, Marketing, Sales, and Legal teams.
• Ensure compliance with FDA and ISO regulations.

Skills

Analytical skills

Communication

Process management

Attention to detail

Proactivity

Job description

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Lensa is the leading career site for job seekers at every stage of their career. Our client, Hologic, is seeking professionals in Marlborough, MA. Apply via Lensa today!

Clinical QA Specialist

Newark, DE, United States

Marlborough, MA, United States

Are you passionate about ensuring the highest standards of quality and compliance in the medical device industry? We are seeking a dedicated and dynamic Clinical QA Specialist to join our team onsite in Newark, DE! In this pivotal role, you will be responsible for the timely and thorough investigation and reporting of Potential Adverse Events, Adverse Events, and other regulatory reporting required due to complaints analysis. You will work closely with Technical Service, Marketing, Sales, Legal, and potentially Customers, fostering seamless communication and collaboration. This role requires your presence onsite, allowing you to make a tangible impact and drive excellence in our operations. Apply today!

Knowledge

• In-depth understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 standards.
• Familiarity with medical procedures and expected outcomes related to the portfolio of products.
• Knowledge of complaint handling, post-market surveillance processes, and regulatory reporting requirements.
  
  

Skills

• Strong analytical and investigative skills to assess adverse events and identify next steps.
• Exceptional verbal and written communication skills to collaborate with internal teams, regulatory bodies, and external stakeholders.
• Proficiency in managing and innovating processes to improve compliance and efficiency in post-market surveillance.
• Ability to work independently while meeting deadlines in a fast-paced environment.
• Adept in handling metrics, indicators, and quality reports related to reportable events.
  
  

Behaviors

• High attention to detail and a commitment to accuracy in reporting and documentation.
• Proactive mindset with a focus on continuous improvement and innovation.
• Collaborative and team-oriented approach to problem-solving.
• Resilient and adaptable, thriving under pressure and regulatory scrutiny.
• Ethical and customer-focused, ensuring patient safety is the top priority.
  
  

Experience

• A minimum of 5 years’ experience in a similar role involving post-market surveillance, adverse event reporting, and regulatory compliance.
• Hands-on experience working with cross-functional teams such as Technical Service, Marketing, Sales, and Legal.
• Track record of successful participation in internal and external audits, as well as regulatory agency interactions.
• Experience in executing investigations like CAPAs, NCEs, and IACAs to resolution.
  
  

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is$83,000 - $129,700and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  IT Services and IT Consulting

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