Quality Engineer

Summary of Position

Supports and implements systems in the areas of validation, advanced quality, risk management, change control, and design and development. Supports the development and enforcement of internal systems and procedures to meet the local Quality Management System, ISO standards, FDA quality system regulation, and other regulatory requirements. Develops and implements inspection/validation techniques necessary to verify products meet requirements at the earliest point in the production process.

Specifies and implements new inspection equipment and instructs others in its proper use.

• Plans, executes, and reports on equipment and process validation.
• Assists with training on quality and compliance concepts and best practices.
• Work with Quality team and cross‑functional teams to conduct quality investigations, identify root causes, and present potential solutions.
• Supports Treatment Planning teams in planning and execution of audits by external partners, regulatory authorities and/or their representatives.
• Creates and maintains the Risk Management program and works with internal team on risk mitigation strategies.
• Creates and maintains the change management program.
• Participates in the development, implementation, and reporting of metrics of interest to local operations, management, and external partners.
• Follows safety rules and maintains personal safety and the safety of others, including maintaining a clean and safe work area.
• Accurately records and reports information as required.
• Follows employee policy within the company.

• Attends Quality and other meetings as required.
• Participates in additional training relevant to this position.
• Other duties may be assigned, directed or requested.

• Must be proficient in English spoken and written language.
• Bachelor's degree in quality, engineering and/or manufacturing fields preferred.
• Must have 3+ years quality control or quality assurance experience in the medical device manufacturing field.
• Ability to work with multidisciplinary teams across multiple countries to execute projects, investigations, and training.
• Demonstrated ability to plan and work to robust timelines.
• Experience in planning, execution and reporting of equipment and process validations.
• Excellent understanding of quality principles and good documentation practices.
• Familiarity with US and International medical device regulations and registrations.
• Must be familiar with, and competent in, conducting and managing Risk Management plans and summaries. Familiarity with ISO 13485 preferred.
• Knowledge of design control processes.
• Experience with managing non‑conformances and CAPA.
• Front and back room audit experience.
• Must be able to utilize basic quality tools including RCA, Fishbone analysis, SPCs, FMEA, checklists, histograms, Pareto, scatter diagrams, process mapping and flow charts.
• Must be able to produce technical documents, testing and validation plans, IQ/OQ/PQ protocols and formal procedures.
• Six Sigma/Lean Manufacturing skills preferred.
• Must have excellent written communication skills.
• Must have basic computer skills (Microsoft Office).

• Resourceful and Hands‑on:
  An energetic, resourceful, agile, and hands‑on individual who operates effectively with minimum direction and pursues objectives and works to deliver against goals relentlessly; able to get to the heart of issues rapidly and act decisively.
• Team Player:
  From a basis of strong self‑awareness, excellent interpersonal skills; fosters team‑first mentality and shares wins and successes; creates an open and transparent environment in which individuals can team together to drive optimal outcomes.
• Results‑driven:
  Brings a fire in the belly and is counted on to meet or exceed commitments on time, every time; has a genuine passion for patient outcomes and quality.
• Collaborative Relationship‑builder:
  Able to build deep relationships with key internal and external stakeholders, and work closely with/ and earn the respect and trust of other teams.
• Integrity:
  Possesses unquestionable integrity and is intellectually curious; is known as an honest, trustworthy,…