Quality Engineer - CARY, NC

Description

The company makes medical technology and works across more than 70 countries with a team of over 72,000 people.

The Quality Engineer role helps shape the customer services quality management system, with a focus on improving the effectiveness of CAPA and document management process controls.

The team includes scientists, clinicians, developers, researchers and specialists from many backgrounds, and its portfolio supports clinical decisions and treatment pathways.

Responsibilities

• Take an active part in audits and work with cross-functional teams to tighten quality processes and keep improving how things are done.
• Lead internal and supplier audits, and work with stakeholders on internal and external audit activity.
• Own and oversee the end-to-end Corrective and Preventive Action (CAPA) process as the CAPA Management Process Manager.
• Run cross-functional CAPA meetings, coach CAPA Owners and Quality Managers, and moderate CAPA Steering Board meetings.
• Act as the customer services subject matter expert on the CAPA process during audits.
• Manage assigned process changes so timelines are met, weighing user needs, operational impact and implementation effort when you develop or contribute to updates.
• Design and keep improving training materials for the processes you are assigned.

Requirements

• Minimum 3 years of experience in quality management systems, within a regulated medical device environment at a global company. 5 to 7 years is preferred.
• Auditor certification is required. Lead Auditor certification is preferred.
• Expert knowledge of standards that apply to medical devices, such as ISO 13485 and FDA 21 CFR QMSR.
• A bachelor's or master's degree in quality, engineering, natural science or a related field is preferred, along with experience in the medical device industry.
• Strong communication skills and intercultural sensitivity, with the ability to work well across teams and regions.
• Sound decision-making that builds consensus across several levels of an organization.
• A customer-focused approach.
• Ability to build presentations for different audiences, adjusting the level of detail and focus to what each stakeholder needs.
• Travel may be required as needed.

Conditions

Travel is required as needed.

Base pay range: $89,220 to $122,672. Starting pay within this range depends on factors such as geography or market, skills, education, experience and other qualifications.

Commission eligibility, if the position is commission eligible, follows the terms of the company's plan and is based on individual and/or company performance.

The company is an equal opportunity employer, and reasonable accommodations are available for people with disabilities.

The role requires the ability to work with controlled technology under US export control law, and the company complies with the EAR, ITAR and OFAC regulations.

Do not send your CV by email. Create a profile in the company's talent community to upload it instead.

Be wary of fraudulent job postings or recruiters posing as the company. Verify any posting on the company's career site.

Benefits

• Medical, dental and vision insurance.
• 401(k) retirement plan.
• Life insurance, and long-term and short-term disability insurance.
• Paid parking or public transportation.
• Paid time off and paid sick and safe time.