Quality Assurance Lead Engineer

Description

You will support engineering processes and QMS management under documented procedures and practices, in a key technical and management role.

You will build, introduce, improve and keep strengthening core Quality Assurance practices across the local business, covering design, design transfer and QMS rollout for the Patient Care Solutions business.

The company is a global maker of medical technology and digital solutions.

Responsibilities

• Build a quality culture by driving compliance for a given product, site or region.
• Own the total quality management system for the business and push quality metrics.
• Keep quality and regulatory compliance in place while making processes more effective and efficient.
• Act as the company's voice to external agencies and drive quality objectives, metrics, reporting and operating mechanisms.
• Deepen your expertise in one discipline and apply past experience to carry out functional policy and strategy.
• Work mainly as an individual contributor, giving informal guidance to newer team members.
• Explain complex information simply in routine situations.
• Influence projects, processes and procedures in your own field.
• Coordinate with colleagues and the business on design and related services.
• Use technical judgment and analytic thinking to solve problems, drawing on several internal sources beyond your team.

Requirements

• Bachelor's degree in engineering or a technical field, or a high school diploma plus at least 7 years in manufacturing, engineering or quality assurance.
• At least 3 years working in a regulated industry.
• Understanding of, or clear aptitude to learn, medical device QMS and regulatory rules such as FDA CFR 21 820 and ISO 13485.
• Willingness to work hybrid, on site three days a week at the Waukesha, Wisconsin office.
• Flexibility with work hours and willingness to partner with and accommodate global teams and schedules.
• Desired: knowledge of QMS tools and continuous improvement methods, plus detailed understanding of site products and their processes.
• Desired: understanding of product development lifecycles, design and document change control, process verification and validation, production process control, and servicing in a medical device setting.
• Desired: ability to explain design controls, design verification and validation, production and process controls, CAPA, complaints, risk management and quality improvement tools such as Six Sigma and DFR to people at every level.
• Desired: collaboration, negotiation and conflict resolution skills.
• Desired: ability to lead, develop and carry out a strategy that ensures compliance, including in crisis situations.
• Desired: strong oral and written communication, report writing and procedure writing.
• Desired: strong analytical, problem solving and root-cause analysis skills.
• Desired: ability to juggle competing priorities.
• Desired: outside view of customer needs, market dynamics, industry trends and competitors, and the external effect of decisions.
• Desired: clear thinking that turns strategy into specific actions with clear ownership, and sound decisions made quickly on the best available information.
• Desired: energy and drive to lead change.

Conditions

Hybrid schedule with three days per week on site in Waukesha, Wisconsin.

Flexible working hours to work with global teams.

No visa sponsorship now or in the future for this role.

You must be legally authorized to work in the United States for this opening.

Any offer is conditional on passing a drug screen, where applicable.

US employees are not currently required to be vaccinated against COVID-19, but some customers may mandate vaccination for certain employees.

Relocation assistance is not provided.