Education/Special Training Required

Bachelor of Science, Engineering or related subject with 2 or more years of experience in a quality or engineering discipline in a manufacturing environment, or

Master of Science, Engineering or related subject with 0 or more years of experience in a quality discipline

Qualifications/Work Experience Required Who We Want

A Quality Engineer with the ability to drive quality and deliver results. Someone who is an advocate for quality and lean methodologies; a self-directed professional who can identify issues and communicate effectively to all levels within the organization; a medical device industry professional who is passionate about providing superior quality products to patients and customers.

Previous experience in a regulated environment desirable (e.g. Medical Device, Aviation, Aerospace, Automative, Defense).

CQE or equivalent course work / experience desirable

Proficient in understanding of Med Device manufacturing processes desirable.

Familiarity with ISO 13485, GDP, GMP desirable.

Lean Six Sigma training a distinct advantage.

Excellent collaboration and communication skills and attention to detail. Able to effectively communicate up/down and across different levels of the organization.

Have a good understanding of engineering and quality practices & methods.

High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.

Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast paced environment.

Must be willing to work as part of a multi-site team, with some travel required.

Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.

Highly developed problem solving and strong analytical skills.

Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach.

Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.

Manages change well and adopts a continuous improvement orientation to the role

Excellent English (both oral and written)

Ability to be the voice of Quality when dealing cross functionally

Additional Job Details:

Essential Duties & Responsibilities: Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:

Work closely with operations and the business functions to ensure quality performance of product and processes.

Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.

Lead and participate in the development and improvement of the manufacturing processes for existing and new products.

Resolve quality issues with suppliers and partner with internal customers.

Review and approval of change management activities.

Maintain KPI for monitoring of process and supplier quality, perform analysis and interpret trends, take action as necessary.

Ownership and reporting on all quality issues associated with assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders.

Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions.

Support execution and analysis of QATs.

Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.

Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.

Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.

Proficiency in statistical methods and application. Proficiency in technical understanding of manufacturing prints and tolerancing.

Support global supplier audit team with key supplier site metrics. Negotiate sustaining quality agreements with suppliers.

Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.

Assist in the development, responsible for review & approval of process and equipment validation/qualification.

Support manufacturing transfers to other plants/facilities, leading quality activities.

Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.

Coach others in quality topics and activities. Main Areas of Focus:

Experience in validations (IQ, OQ, PQ)

Familiarity with Incoming inspection and part certification For your role, is this hybrid, remote or onsite

Onsite Is a degree required

Yes, Bachelors in an engineering or science discipline. Top 3 skills 1. Adaptability 2. Attention to Detail 3. Problem solving Interview (1, 2 rounds Onsite or virtual)

1 or 2. (Still confirming with my manager) Temp to perm or just contract

Just a contractor. But if a position does open up we are ok with them applying for the full time position. Can you give us an overview of the project this resource would be working on and what the day-to-day activities would look like

Working on: o This project will be supporting daily production line support when needed. Such as quality decision making on rejected material or not following the process. o Performing software and equipment validations for incoming inspection.

Completing part certifications on supplied raw materials.

Day-to-day o Checking on production o Progress/close NCs o Progressing validations o Progressing part certs. o The majority of the time will be spent at a computer