- Detail-oriented independent self-starter who is capable of planning and executing project schedules in a timely manner implementing and abiding by applicable FDA, ASTM and ISO standards.
- Matured ability to manage multiple projects simultaneously without supervision. This includes creating detailed and accurate project tasks and schedules, interfacing with project team members, external suppliers and other support personnel and solving project-related conflicts and issues.
- Firsthand participation with Design Controls per ISO 13485:2016.
- Develop and execute verification and validation plans and protocols associated with product/process quality.
- Keen understanding and demonstrated ability to independently create and maintain risk management files per ISO
- Independently perform root cause investigations, develop and implement corrective action plans (if necessary) considering impact to risk for product quality post-launch.
- Review/generate ECO's to ensure compliance to Quality System, impact to validation and verification testing and impact to risk for new and sustaining products activities.
- Act as liaison between quality and project engineers to ensure that inspection process capabilities have been verified and appropriately documented.
- Provide authoritative guidance about Six Sigma principles (Sampling, Acceptance Criteria, DOE, Statistical Process Control, Root Cause Analysis, FMEA, control charts, capability analysis) as well as guidance on Design Control elements to New Product Development team members and Manufacturing Staff.
- Awareness of General TSI Quality Management System (QMS), Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Complaint Handling through annual TSI Training.
- Other responsibilities assigned by supervisor and including vendor site audits, attending cadaver labs and general corporate functions associated with role as Quality Engineering professional.
- Min 3 years' work experience in a Quality Engineering role, in the medical device industry, with a history of successful participation in Product Development teams and Risk Management activities.
- Strong working knowledge of Design Controls, manufacturing process controls
- Understanding of human factors engineering and usability requirements
- Demonstrated successful application of analytical quality tools
- Computer literate in various software applications. (i.e. - Word, Excel, Access, Minitab.); Solidworks experience preferred
- Independent organization and prioritization of multiple tasks
- Communication: Ability to internally and externally discuss and clearly define key technical and process development issues and independently develop course of action/plans
- Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing/inspection procedures
- Interpersonal: Ability to cooperate and support team members and ability to coordinate interdepartmental activities and to resolve individual conflicts and issues.
- Business Acumen: Require a basic understanding of business and financial impact of project.
- Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Abide by team decisions.
- Bachelor of Science (B.S.) degree in Biomedical or Mechanical Engineering with experience in the medical device industry
- Experience in Process Validation/Process Capability
- Business casual attire.
- Occasionally requires attending corporate functions.
- Occasionally may require travel (5-10%).
-
Quality Engineer
3 days ago
TeDan Surgical Innovations Sugar Land, United StatesCompany description: · TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. · TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery ...
-
Quality Engineer
1 week ago
AOI Sugar Land, United StatesSUMMARY · The Quality Engineer will be responsible for the development and execution of all quality perspective and its subsidiaries and operations in optical components, including but not limited to RMA FA, RMA status analysis, inline quality control, final quality control, and ...
-
Quality Engineer
20 hours ago
TeDan Surgical Innovations Sugar Land, United StatesCompany description: · TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. · TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surge ...
-
Quality Engineer
1 week ago
OTT Solutions, LLC West Bend, United StatesJob DescriptionJob Description · Title: Quality Engineer · Location: West Bend, WI · Job Summary: · Our client is continuing to add talent to support business growth and is looking for a Quality Engineer This organization is a complete one-stop shop for Turnkey Automation Sol ...
-
Quality Engineer
5 days ago
Applied Optoelectronics Sugar Land, United StatesSummary · The quality engineer will be responsible for the development and execution of all quality perspective and its subsidiaries and operations in wafer and chip process, including but not limited to incoming quality control, inline quality control, final quality control, qu ...
-
Quality Engineer
1 week ago
Accredo Packaging Sugar Land, United StatesIt's fun to work in a company where people truly BELIEVE in what they're doingWe're committed to bringing passion and customer focus to the business.Accredo Packaging, Inc. is a leading manufacturer and supplier of traditional and sustainable flexible packaging for the pre-packag ...
-
Quality Engineer
5 days ago
Applied Optoelectronics Sugar Land, United StatesSummary · The quality engineer will be responsible for the development and execution of all quality perspective and its subsidiaries and operations in wafer and chip process, including but not limited to incoming quality control, inline quality control, final quality control, qu ...
-
Quality Engineer
5 days ago
AOI Sugar Land, United StatesSUMMARY · The Quality Engineer will be responsible for the development and execution of all quality perspective and its subsidiaries and operations in optical components, including but not limited to RMA FA, RMA status analysis, inline quality control, final quality control, and ...
-
Quality Engineer
1 week ago
AOI Sugar Land, United StatesSUMMARY · The Quality Engineer will be responsible for the development and execution of all quality perspective and its subsidiaries and operations in optical components, including but not limited to RMA FA, RMA status analysis, inline quality control, final quality control, and ...
-
Quality Engineer
1 week ago
Accredo Packaging Sugar Land, United StatesIt's fun to work in a company where people truly BELIEVE in what they're doing · We're committed to bringing passion and customer focus to the business. · Accredo Packaging, Inc. is a leading manufacturer and supplier of traditional and sustainable flexible packaging for the pr ...
-
Quality Engineer Senior
1 week ago
ACUITY BRANDS LIGHTING, INC. Houston, United StatesUtilizamos la tecnología para resolver problemas en espacios, luz y más cosas por venir... para nuestros clientes, nuestras comunidades y nuestro planeta. · Acuity Brands, Inc. (NYSE: AYI) es una empresa de tecnología industrial líder en el mercado. Utilizamos la tecnología para ...
-
Quality Systems Engineer
1 week ago
Alfred Kärcher SE & Co. KG Houston, United StatesPulsar Tabulador para desplazarse para pasar el enlace del contenido · * Realizar auditorías de proceso basadas en la norma de gestión de calidad ISO 9001 y ambiental ISO 14001. · * Elaboración de Reporte de 8 Disciplinas. · * Apoyo en decisiones de rechazos en recibo y línea (ba ...
-
Quality Engineer
1 week ago
Emerson Stafford, United StatesJOB DESCRIPTIONIf you are a Quality Engineer professional looking for an opportunity to grow, Emerson has an exciting opportunity for you Based in our Stafford, TX location, this role will handle and be responsible for overall product quality and process improvements in the areas ...
-
Quality Engineer
2 days ago
Emerson Group Stafford, United StatesJob Description · If you are a Quality Engineer professional looking for an opportunity to grow, Emerson has an exciting opportunity for you Based in our Stafford, TX location, this role will handle and be responsible for overall product quality and process improvements in the a ...
-
Quality Engineer
1 week ago
Emerson Group Stafford, United StatesJob DescriptionIf you are a Quality Engineer professional looking for an opportunity to grow, Emerson has an exciting opportunity for you Based in our Stafford, TX location, this role will handle and be responsible for overall product quality and process improvements in the areas ...
-
Quality Engineer
1 week ago
Emerson Stafford, United StatesJOB DESCRIPTION · If you are a Quality Engineer professional looking for an opportunity to grow, Emerson has an exciting opportunity for you Based in our Stafford, TX location, this role will handle and be responsible for overall product quality and process improvements in the a ...
-
Quality Engineer
1 week ago
Emerson Stafford, United StatesJOB DESCRIPTIONIf you are a Quality Engineer professional looking for an opportunity to grow, Emerson has an exciting opportunity for you Based in our Stafford, TX location, this role will handle and be responsible for overall product quality and process improvements in the areas ...
-
Quality Engineering Specialist
1 week ago
Astrix Stafford, United StatesGreat development opportunity to work for a leading global consumer-centric medical device company is looking for a Quality Engineering Generalist. This is your chance to work with a global company with nearly 13,000 employees located in 30 countries · Quality Engineering Special ...
-
Quality Engineering Generalist
1 week ago
CooperSurgical Stafford, United StatesAbout CooperSurgical CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of d Quality Engineer, Generalist, ...
-
Quality Engineer Generalist
1 day ago
Astrix Technology Stafford, United StatesQuality Engineer Generalist · Engineering · Stafford, TX, US · Pay Rate Low: 40.86 | Pay Rate High: 48 · + Added - 15/05/2024 · Apply for Job · _Our client, a Medical Device Manufacturer, is looking for a Quality Engineering Generalist to join their rapidly growing HR team. ...
Quality Engineer - Sugar Land, United States - TeDan Surgical Innovations
Description
Company description:
Are you the right candidate for this opportunity Make sure to read the full description below.TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries.
TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.
Job Summary:
The Quality Engineer is responsible for quality engineering activities to support the product life cycle, from development of new products from concept through commercialization, through sustaining changes, as part of a cross-functional development team. The Quality Engineer is an active participant in the generation of documentation related to design concepts, specifications, quality and manufacturing requirements, process/technology development, product/process verification/validation protocols and reports, risk management assessments and maintenance of life cycle sustaining products. Responsible for tasks (product and process) specific to the quality of designated product line(s); including manufacturability capability and awareness, and the investigation and corrective actions of customer complaints and nonconforming product. The QE provides coaching to Design Engineers and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families.
generation of documentation related to design concepts, specifications, quality and manufacturing requirements, process/technology development, product/process verification/validation protocols and reports, risk management assessments and maintenance of life cycle sustaining products. Responsible for tasks (product and process) specific to the quality of designated product line(s); including manufacturability capability and awareness, and the investigation and corrective actions of customer complaints and nonconforming product. The QE provides coaching to Design Engineers and Manufacturing personnel on Quality System Requirements and process improvement methodologies for their product families.
Duties/Essential Job Functions:
Knowledge/Skills/Experience:
Required Education/Licensing/Certification:
Physical Requirements:
