Continuous Improvement Quality Engineer (CIQE)

Description

You will help make sure quality systems, products and manufacturing processes meet quality standards, driving improvements in line with international practices and rules such as ISO 13485 and 21CFR820.

The role gives expert support on nonconformance (NC) and corrective and preventive action (CAPA) work, works alongside subject matter experts on NC/CAPA activities and supports other improvement projects.

You will refine existing processes and systems so quality issues are escalated on time and investigated thoroughly within a closed-loop quality management system.

Responsibilities

• Follow the company and site health, safety and environment programs and requirements, wearing personal protective equipment (PPE) where needed.
• Use devices, accessories, tools and equipment as the process specifies, check they are in good condition and report any that need repair.
• Report unsafe acts or conditions to your manager.
• Take part in the health, safety and environment courses set for you.
• Keep your workstation orderly and clean under 5S.
• Follow health regulations, ISO 13485, company and site policies, operating procedures and task assignments.
• Take part in or lead NC and CAPA projects, keeping records compliant, accurate and on time.
• Communicate clearly with managers at all levels, peers and key stakeholders, escalating quality issues promptly.
• Lead and work with cross-functional teams using methods such as Six Sigma root cause analysis and problem solving.
• Investigate independently, gather data and trends, and carry out preliminary analysis.
• Handle requests by assigning subject matter experts and action item owners, and respond on time to meet quality goals.
• Lead NC and CAPA update meetings and communications, covering news and concerns.
• Help with metrics and reporting according to established procedures.
• Help deliver and oversee the NC and CAPA training program.
• Help start, process and complete NC and CAPA records in the electronic system.
• Deliver Quality Engineering deliverables on time.
• Support audits and inspections with NC and CAPA process and system expertise.
• Help review and approve documents required by NC and CAPA deliverables.
• Mentor CAPA teams and colleagues who are new to NC and CAPA processes and systems.

Requirements

• Minimum 4 years as a quality engineer in systems, assurance or quality control.
• Minimum 4 years in a regulated manufacturing industry such as medical devices, pharmaceuticals, aerospace, automotive or food.
• Minimum 4 years of NC and CAPA and/or engineering work, using quality tools and methods.
• Minimum 3 years of detailed knowledge of Quality System Regulations (21CFR820) and ISO 13485.
• Able to work in a highly matrixed, geographically spread business.
• Strong focus on quality, compliance and detail.
• Critical thinking to assess risk, use root cause analysis and collect and analyze data to choose an improvement strategy.
• Expertise in cGMP and NC/CAPA documentation.
• Advanced Microsoft Office skills, plus statistical and data analysis and report writing.
• Proven project management and leadership, including leading multi-department project teams and resolving quality issues quickly and effectively.
• Able to work in a team or alone in a fast-paced, changing setting.
• Able to engage others to deliver projects.
• Clear verbal and written communication at every organizational level.
• Manage multiple tasks, set priorities and meet deadlines.
• Strong interpersonal, organizational and follow-up skills.
• Motivated to improve products and processes.
• Bachelor's degree in engineering, preferably in science or healthcare fields.
• Preferred: ASQ certification such as CQE or CQA, and knowledge of process improvement tools and methods such as Lean and Six Sigma.
• Preferred: NC or CAPA review and approval project management experience.
• Preferred: experience in a broader enterprise or cross-division business unit model.
• A Green or Black Belt certification in Lean or Six Sigma is a plus.

Conditions

Work is based at a desk and in meeting rooms.

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

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

The company may require proof of current vaccination against certain diseases, including COVID-19, depending on the role and customer.

Some roles may be subject to U.S. export controls for candidates who are nationals of embargoed or sanctioned countries, and the government licensing process can take 3 to 6+ months.

A Technology Control Plan (TCP) may be needed, typically adding 2 weeks to hiring.

Final offers are contingent on an approved export license and/or an executed TCP before the start date, which may or may not be flexible.

Preference is given 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.

Qualified applicants with arrest and conviction records are considered in line with fair chance laws.