Senior (Quality Engineer 4) - Endoluminal Systems

Description

This role covers quality work across the Endoluminal product family and its operational area. The scope runs from on-site manufacturing and supplier operations to product design and customer complaints, and includes risk management, new product development and company-wide improvement work.

The team is responsible for the full chain of quality activity, so you will work across sites and departments on problems that affect several groups at once.

Responsibilities

• Lead investigations and audits of products and processes that affect more than one site or function.
• Find systemic quality problems and push for fixes that hold over time.
• Own investigations into customer complaints and non-conformances.
• Act as the escalation point for medium to high impact product quality and compliance risks.
• Write, review and approve QA documents and protocols.
• Drive corrective and preventive actions (CAPA) and process non-conformances to closure.
• Own risk assessments and process reviews.
• Help prepare for and respond to regulatory and customer audits.
• Analyze advanced quality data and KPI trends.
• Coach junior engineers and technicians so they build their technical skills.
• Make sure work meets company requirements and regulatory standards including GMP, ISO and FDA rules.
• Advise cross-functional teams on quality requirements.
• Identify and lead continuous improvement projects.
• Own quality outcomes for a product family, a plant or a major operational area.
• Lead improvements that affect several teams or value streams, often without formal authority over those teams.
• Develop junior quality engineers until they can work as independent owners of their areas.
• Shape decisions through technical expertise and credibility.

Requirements

• At least 8 years of experience in quality engineering or QA, plus a bachelor's degree in engineering or a related field. An equivalent mix of education and experience is accepted.
• At least 2 years of experience in a regulated industry, in a relevant discipline.
• Experience supporting new product introduction from design and development through to manufacturing transfer.
• Demonstrated experience supporting mechanical assembly of electro-mechanical systems, including multi-component assembly processes.
• Skill in designing and putting in place inspection at upstream and downstream stages so defects are caught early and at the right point.
• Strong grasp of quality principles and methods.
• Strong data analysis and interpretation skills.
• Strong ability to drive quality issues to resolution.
• Strong communication and teamwork skills, with the ability to influence stakeholders across departments.
• Travel to offices, labs, production areas and sites as needed, up to 10% of the time.
• Frequent computer work and inspection work.
• Occasional lifting of up to 25 lbs, and wearing PPE in production or regulated areas.

Conditions

Proof of current vaccination against certain diseases, including COVID-19, may be required by the company or its customers. Requirements can differ by role.

Some roles are subject to U.S. export controls. Where this applies, the offer depends on an approved export license and/or an executed Technology Control Plan (TCP) before the start date. Licensing can take 3 to 6+ months, and a TCP typically adds about 2 weeks to hiring. Candidates will be told if this applies to them.

Candidates with arrest or conviction records are considered in line with fair chance laws.

Preference goes to qualified candidates who do not live, and do not plan to live, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina or Tennessee.

The role may be filled at a different job level than advertised, depending on business need and the selected candidate's experience, knowledge and skills.

Pay is based mainly on the job level the role is filled at and the candidate's qualifications, in line with applicable law.