2 Quality Specialist - CAPA Jobs in Portsmouth, NH

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Quality Specialist 1

SubCom

Portsmouth, NH | Full Time

$79k-97k (estimate)

1 Week Ago

Quality Specialist - CAPA

Laborie Medical Technologies

Portsmouth, NH | Full Time

$84k-101k (estimate)

2 Months Ago

Quality Specialist - CAPA

$84k-101k (estimate)

Full Time 2 Months Ago

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Laborie Medical Technologies is Hiring a Quality Specialist - CAPA Near Portsmouth, NH

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the Quality team, the Quality Specialist - CAPAwill help to develop, establish, and maintain assigned quality management system processes to ensure compliance with applicable regulations and standards. The main purpose of this job is to provide leadership and oversight of the Corrective Action and Preventive Action (CAPA) process.

About the Role:

Manage the CAPA process by:
- Evaluating potential nonconformances and systemic issues that may need to be addressed.
- Ensuring CAPA owners are assigned and are completing actions in compliance with the CAPA process.
- Performing CAPA record administration in the electronic system.

Ensure assigned Quality Management System processes are efficient and compliant by:
- Monitoring the process using metrics, taking action to improve efficiency and ensure compliance, and reporting results to management.
- Maintaining a thorough knowledge of new and existing regulatory requirements and updating assigned processes.
- Participating in internal and external audits of assigned processes that assess compliance.

Minimum Qualifications:

Bachelor’s degree in an engineering or scientific field with a minimum of 5 years of job experience in the medical device industry.
Experience with the medical device internal and external audit processes. Quality auditor certification preferred.
Strong communication and computer literacy skills with high level of proficiency with Microsoft Office.

Preferred Qualifications:

Experience using electronic systems to administer quality records is preferred.

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.

Paid time off and paid volunteer time
Medical, Dental, Vision and Flexible Spending Account
Health Savings Account with Company Funded Contributions
401k Retirement Plan with Company Match
Parental Leave and Adoption Services
Health and Wellness Programs and Events

We are interested in a qualified candidate who is eligible to work in the United States. However, we will not be sponsoring work visas for this position, at this time.

Laborie providesequal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation, or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.