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We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
Assuring production line compliance and working closely with the QA at the contracted manufacturer.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
Guidance by the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA

As a Supplier Quality engineer, you will have responsibility for leading Afimilk quality assurance day to day quality activities and projects. This role provides quality support for operations, manages our contract manufacturing suppliers (quality/eng oriented) and ensure the overall quality of Afimilk manufactured products, supports and monitoring the production and processes to meet high quality standards. You will also be the leader in defining and implementing quality systems and processes to drive continuous product and process improvement. Essential Duties and Responsibilities include the following (Other duties may be assigned):
* Day-to-day quality engineering activities such as product quality documentation, customer complaints, ECO's, product deviation, non-conformities, FAI, Document control and fields corrective action. · Manage/Support investigations of escalation, deviations, CAPA's, risk assessments, FMEA, root-cause analysis activities internal or supplier sites. · Responsible for leading and implementing IPQC, IQC, OQC approval to supplier. · Collect, analyze, and interpret statistical data, perform analyses, and provide reports as required.
* Actively involved in the NPI process
* Leading and continuously improving company's Quality Management System and quality engineering activities, Monitor, and analyze quality performance and KPI. · Develop and maintain successful external auditing plans for Suppliers and their 2nd tier. · Collaborate with Operations, R&D QA, Engineering and Manufacturing functions to ensure quality standards are in place. · Takes an active role in leading, reviewing, and approving quality manufacturing product changes. · Validation of manufacturing process to meet targets, production output and quality standards.

Personal Attributes:
· Technical capabilities. · Experience in utilization of statistical techniques such design of experiments, hypothesis testing, SPC, etc. as part of Quality Engineering discipline. · CMQ/OE, CQE – Advantage · Experience in Plastics manufacturing Engineering, including with Paint and/or Injection Molding technologies. · Experience with Priority ERP system – an advantage · Experience in mass-production - an advantage · Proficient in documentation · High Learning ability

We are looking for a ATE Engineer.
In this role, you will:
Develop automated HW ATE - SRS, scripts and logic.
Integrate with other applications API.
Create and run ATE in production line with DB connection.
Work in a scrum team applying agile methodology.
Automate test cases from requirements and manual tests as part of scrum team developments.
Collaborate with other applications teams.
Work with bugs stored in bug tracking system: identifying bugs, documenting, fixing, communication with software developers and internal customers.

We are looking for a Director Supplier and Production Quality.
This position will focus on improving product quality through data analysis,
investigation, issue resolution and collaboration with both internal and external parties. This person will be responsible for driving the non-conforming material process and root cause investigation through coordination with engineering & R&D organizations.
You will be responsible for making final decisions on production and supplier quality along with ensuring NPI, engineering, supply chain and fulfilment as well as production effective achievement of quality and compliance objectives.
In the role of Production & Suppliers Quality director you will oversee iTero production in various global facilities; youll also be managing suppliers and contract manufactures for iTero from around the globe.
In this role, you will:
Drive product quality improvements in production and with suppliers
Manage a team of quality engineers & the QC Dept.
Manage the NCM and MRB processes.
Lead analysis of defects data (NCM, RMA and DOA)
CAPA/ SCAR creation / resolution and maintain records as specified by the quality system
Lead QC team and drive incoming inspection improvements, such as direct- to- stock, reduction of MRB and non-conforming material inventory.
Interface with other functions on supplier related defects
Conduct root cause analysis on product quality issues, identify trends, and communicate with Engineering/ R&D on a regular basis.
Be responsible to oversee that Operations are working according to released and validated work instructions to ensure that a device conforms to its specifications.
Be responsible for process- related Validations across the company process, support SW, mold, jigs
Ensure the creation of accurate, complete and timely records and DHRs
Set the yearly suppliers audits plan and execute with the team
Be responsible for evaluating current suppliers, approving new suppliers and disqualifying suppliers
Support the introduction of iTero production lines in other facilities around the globe and with external contract manufacturers.
Work with our Global on the integration and harmonization of Purchasing controls and Production and process controls related SOPs, suppliers audits and supporting IT systems.
Support PFMEA creation and update and any other process and suppliers' risk- related activities
Additional responsibilities:
Be aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/ position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required.
Support external bodies audits on- site
Perform internal audits.

We are looking for a Design Quality Engineer.
The Design Quality Engineer is responsible for driving exceptional product quality for the patient safety, customer value beyond expectations, regulatory assurance, and optimized Cost of Quality for the Company. This is a key technical position, affecting part quality for both installed base and NPI products.
AS a Design Quality Engineer (DQE) you will plays a crucial role in ensuring the safety, efficacy, and regulatory compliance of medical equipment including cooperated with the design and development team, and apply quality management principles throughout the product life cycle.
DQE's main responsibilities include:
Review design documents and specifications, to ensure that they meet relevant standards and regulations
Participant in risk assessment, identify and reduce potential risk quality
Take part in the design and verification process