Quality Engineer  Jobs

Strong interpersonal skills with the ability to smoothly interact with all levels of management and employees

Educate, train, & advise company professionals to ensure compliance with RA requirements

BS degree in Engineering or a related field or equivalent experience required.

Strong knowledge of electro-mechanical systems manufacturing

Strong knowledge of statistical process control, IQ/OQ/PQ, CAPA, supplier quality, FMEA, six sigma tools, and Lean manufacturing techniques.

Hands-on experience dealing with FDA Inspections.

Some software quality experience strongly preferred

Proven experience as a Quality Engineer, ideally in medical device manufacturing

Strong analytical and problem-solving skills.

Assist in risk assessments, familiarity with ISO 14971 required

Support regulatory submissions from a quality standpoint

Assist in preparation for internal and external audits

**We will also considered candidates with 3+ years of specific Quality Experience no degree. Other Qualifications:

2+ years experience in a similar role / environment.

Experience in process improvement, supplier quality assurance, welding cells, destructive and non-destructive testing, and supervision are a plus.

Fundamental knowledge of calibration of measurement devices.

Leads investigation, & resolution of product and process non-conformance and helps determine corrective actions

Take part in continuous improvement initiatives, helps with problem solving and helps determine root cause analysis.

-Automotive background experience (IATF 16949 Automotive Quality Management -System in particular) to support EV business.

-Knowledge of statistical techniques and demonstrated ability to review and approve test plans, qualification reports, drawings, documents

-Time Management — Managing one's own time.

Ensures manufacturing and assembly processes/procedures utilized by Contract Manufacturers meet product quality and reliability requirements.

0-3 years of previous experience of Electric Product

-Previous quality assurance intern experience in the electronics or power industry.

Oversee the Medical Device Reporting (MDR) decision-making process to ensure timely reporting and resolution of MDRs in compliance with FDA requirements

5+ years experience working under medical device quality systems

Ability to understand and clearly articulate FDA Quality System Requirements and guidance related to medical device and software development

Excellent verbal and written communication and collaboration skills with proficiency in technical writing

Digital therapeutics and startup experience is a big plus

You are comfortable working in a fully remote setting

Bachelor's degree in mechanical or industrial engineering, production/operations management, or related technical field.

Plan, manage and report workload while proactively communicating foreseeable challenges.

Three to five years of experience in quality engineering in a manufacturing environment. Automotive experience is highly desirable.

Experience with ISO 9001 (experience with ISO 9001:2015, TS 16949, IATF 16949, or VDA is a plus).

Demonstrated knowledge of methodologies to ensure repeatability such as Cp, Cpk, Pp, & Ppk.

Demonstrated experience with Process Failure Mode & Effects Analysis (PFMEAs).

Degree in Mechanical, Materials, or Biomedical Engineering with minimum 4 years of experience

Experience in 483 / Audit remediation for supplier-related problems.

Working independently with the internal and external stakeholders for execution.

Provides Quality Engineering support for commercial Medical products.

Apply various engineering principles including metallurgy, heat transfer, strength of materials, statics, sterilization, and biocompatibility.

Present technical data to groups within and outside the organization.

Advanced Knowledge of customer and ISO9001:2015 / IATF16949: 2016 requirements.

Possesses excellent verbal and written communication skills

Coordinate tasks/responsibilities to production personnel regarding Quality issues

Train and mentor quality and production personnel as required (Customer requirements, etc.)

Implement new procedures and processes in prototype stages of product launches in compliance with customer specific requirements

Post-secondary graduate with a degree/diploma in Quality Engineering and/or Mechanical/Automotive Engineering or equivalent work-related experience in the Quality field.

Quality experience supporting high-volume automated manufacturing o Strong/extensive experience writing or approving nonconformances.

Supporting general operations quality function to support business needs for increased production.

Supports nonconformances, CAPA, and best practices, etc. for all production areas & general quality/compliance.

·Proficient in project management, data analysis, root cause analysis, communication, and risk determination

·2 years of relevant experience in a regulated industry (FDA environment preferred)

·Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

·Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.

·Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation

·Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization

Perform project management of quality plans or other projects

Identify and implement Quality Management System improvements.

SupportRoute92Medical'seffortstosustainabestpracticeQualitySystemby ensuringcompliancetoregulatoryrequirementssuchasFDAQSR,ISO13485andtheEUMDR,andthatproductsmeetallapplicableinternalandexternalrequirements,fromnewproductconception, development, through productlaunch.

At least 3-4 years of experience as a Quality Engineer.

At least 2 years of experience in a medical device regulated environment.

Experience with sampling plans and other statistical methodologies.

Project management experience and ability to use Project Management software to plan, monitor and control activities.

Minimum of 5 years of engineering or manufacturing experience in a quality-oriented field.

Ability to manage and inspire a diverse cross-functional team working on simultaneous projects in a fast-paced environment.

Excellent computer literacy, including knowledge of shortcut keys.

Experience using OGP Vision Systems, QVI Zone3 Metrology software, or equivalent CMM technology.

Working knowledge of ISO9001, ISO13485, and U.S. FDA Code of Federal Regulations - (CFR) Title 21 is a plus.

Knowledge of quality systems, regulatory requirements, and industry standardsBlueprint reading and GD&T expertise

Offer quality support including inspection development, PFMEA, material issue resolution, and maintenance of quality documents.

Knowledge and ability to use appropriate measuring devices

3 + years of experience with quality assurance in manufacturing

Microsoft Platform with CAD experience

Analyze data and identify improvement opportunities based on samples

Provides ongoing quality engineering support to operations, including risk management, developing appropriate inspection requirements; and complaint/NC/CAPA investigations.

0 - 3 years of manufacturing experience, or an equivalent combination of education and experience.

Responsible for ensuring compliance with Avalign procedures, customer requirements; and industry regulations, including FDA Quality System Regulation and ISO 13485.

Feel stuck – we offer great opportunities to advance and learn

A quick learner who is always ready to gain depth of knowledge in manufacturing processes

Serves as a quality representative to assigned manufacturing areas and/or customers.

Ensure processes comply with the Quality Management System

Complete process audits based on requirements of certifications and QMS

High computer competence, including MRP, MS Office, Database management

Bachelor’s degree in technical field preferred, or relative experience

Strong analytical, problem-solving, and decision-making, critical thinking, and leadership skills

Excellent verbal and written communication skills

You should also be aware of FMEA and how it integrates to the overall Risk management process.

You are expected to have several cycles or projects experience in working with Risk files or remediating risk files.

Good Communication skills and proactive behaviour expected.

We offer great benefits, including a 100% remote work environment, flexible schedules, and ongoing growth opportunities

Proven experience utilizing QA/QC management reporting tools, such as Zephyr or XRay

We are a remote-first, geographically-distributed team open to candidates from around the world

Good analytical, critical thinking, and problem-solving skills

Communication skills and an ability to collaborate cross-functionally

Posses Quality Assurance certifications, such as CSTE, CSQA, or ISTQB

We offer great benefits, including a 100% remote work environment, flexible schedules, and ongoing growth opportunities

Proven experience configuring and utilizing QA/QC management reporting tools, such as Zephyr or XRay

We are a remote-first, geographically-distributed team open to candidates from around the world

Progressive experience in software testing with a history of technical leadership roles

Excellent analytical, critical thinking, and problem-solving skills

Strong communication skills and an ability to collaborate cross-functionally

Provide support to the overall Quality Management System (QMS) in support of customer requirements, company goals and quality initiatives.

Manage teams to facilitate Root Cause Analysis and drive product and process improvements.

Produce and deliver quality reports per contract requirements, working with production personnel, technical resources and subject matter experts as needed.

Meet with design and production engineering team to determine quality assurance parameters and implement requirements with production environment.

Develop training and documentation materials for production to enable the seamless knowledge transfer of manufacturing processes.

Member of the Failure Review Boards (FRB) representing the Quality Department for all Quality and reliability issues.

Provide support to the overall Quality Management System (QMS) in support of customer requirements, company goals and quality initiatives.

Manage teams to facilitate Root Cause Analysis and drive product and process improvements.

Produce and deliver quality reports per contract requirements, working with production personnel, technical resources and subject matter experts as needed.

Meet with design and production engineering team to determine quality assurance parameters and implement requirements with production environment.

Develop training and documentation materials for production to enable the seamless knowledge transfer of manufacturing processes.

Member of the Failure Review Boards (FRB) representing the Quality Department for all Quality and reliability issues.