Are you inspired by a fast-paced, innovative environment that will challenge you to find creative solutions? At Balt, we foster a culture of collaboration that drives constant innovation. Our goal is to enhance the care of patients with neurovascular disease through physician-inspired innovative solutions. Balt’s 40 year legacy of bringing first-to-market products is now in the US. We are looking for dedicated, creative and collaborative individuals to join us in building the next great neurovascular device company. If this sounds like you, please select from our open positions below.

Quality Engineer

Job duties:

Perform quality inspections according to written procedures.

  • Conducts product complaint investigations and reporting per written procedures.
  • Assist in the development of new inspection and test methods.
  • Provide feedback to QA, Operations and R&D on quality issues.
  • Assist product development team members in initiating document changes.
  • Reads notes and instructions written on source documents and compares

information with printouts to detect errors and ensure completeness and conformity
with establishment policies and procedures.

  • Participates in risk management activities including the development of product and

process risk analysis, failure mode and effect analyses (FMEA), and risk assessments.

  • Supplier assessment, control, and performance evaluation.
  • Active participant in NCMR and CAPA meetings. Assists with root cause

investigation, preventive and corrective action implementation and closure.

Desired Skills

  • Inspection techniques, including review and understanding technical documentation including mechanical drawings.
  • Excellent written and oral communications, including reading technical documentation.
  • Working in controlled environments (clean rooms), as required.
  • Good intra-personal skills.
  • Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing.
  • Plans, documents (protocol and reporting) product/process validations.
  • Customer compliant device investigations and reporting.
  • Initiates and/or verifies corrective and preventative actions resulting from
  • NCMR’s, audit findings and customer complaints.
  • Identify/evaluate quality inspection/test equipment requirements.

Senior Design Quality Assurance Engineer- MDR Systems Remediation

Description

The Sr. DQA Engineer is responsible for the remediation activities and implementation of the new Medical Device Regulations (MDR) program and maintaining procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. Develops and implements systems to improve the detection and prevention of quality failures. Process improvements; analyzes nonconforming product/process/material issues. Provides guidance and training to Quality personnel and employees of the company regarding the Quality System.

Job Responsibilities

1. Responsible for remediation activities and implementation of the Medical Device Regulations (MDR) program throughout the company.

2. Responsible for maintaining procedures (SOP’s) in compliance to MDR guidelines and applicable regulatory requirements.

3. Ensure that the quality system in place assures product quality and regulatory compliance per MDR, ISO13485 and other applicable international regulations, including MDD and MSAP country requirements

4. Standard Operating Procedures review/approval, Drawings/Specifications review/approval, Change Orders review/approval, Quality Systems Manual review and company-wide training.

5. Responsible for authoring, reviewing and approving test protocols and reports for Design Verification and Validation activities

6. Participates in risk management activities including the development, creation and implementation of product process risk analyses, including: Design, Process and User FMEA’s, product biological risk assessments and associated risk documentation per company internal risk management procedures.

7. Advocate for the promotion of awareness of regulatory and customer requirements per MDR guidelines throughout the organization.

Qualification Requirements Skills
1. Inspection techniques including review and understanding of technical documentation and mechanical drawings.

2. Knowledge of quality requirements for medical device manufacturing and

requirements for inspection and testing.

3. Understanding of MDR guidelines and application in the medical device industry.

4. Understanding of quality management systems for medical devices per ISO 13485

Pre-requisites/Job Experience

1. Bachelor’s degree in engineering or other technical discipline preferred.

2. Minimum 7 years in quality control for medical device manufacturing

3. Excellent knowledge of ISO 13485

4. Excellent knowledge of MDR guidelines and remediation activities

Physical Requirements
1. Moderate lifting.

2. Extended microscope and computer usage.

3. Extended periods of walking or standing.

Sr. Design Quality Assurance Engineer- Design Control

Description

The Sr. DQA Engineer is an integral member of the new product development team. This position will work closely with counterparts within the Marketing & Sales, Engineering and Clinical groups to assure that the products derived are done so in accordance with the Quality System and the Company milestones.

The Sr. DQA Engineer also develops, implements and maintains procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. Develops and implements systems to improve the detection and prevention of quality failures. Process improvements; analyzes nonconforming product/process/material issues. Provides guidance and training to Quality personnel and employees of the company regarding the Quality System.

Job Responsibilities

1. Quality Assurance representative during the Design Control and Design Review process through documentation review and approval of the applicable Design Input, Design Output, Design Verification, Validation, and Design Transfer deliverables.

2. Responsible for Design Control, Device Master Record & Device History Records, Standard Operating Procedures review/approval, Drawings/Specifications review/approval, Change Orders review/approval, Quality Systems Manual review and company-wide training.

3. Responsible for authoring, reviewing and approving test protocols and reports for Design Verification and Validation activities

4. Active participant and leadership in Design and Phase Review meetings per design control internal procedures.

5. Participates in risk management activities including the development, creation and implementation of product process risk analyses, including: Design, Process and User FMEA’s, product biological risk assessments and associated risk documentation per company internal risk management procedures.

6. Ensure that the quality system in place assures product quality and regulatory compliance per ISO13485 and applicable international regulations, including MDD and MSAP country requirements.

7. Advocate for the promotion of awareness of regulatory and customer requirements throughout the organization.

8. Influences the product development process through core team lead and has responsibility for effective transfer validation to operations to assure product quality and regulatory compliance

9. Integral part of project team to launch new products.

Qualification Requirements Skills
1. Inspection techniques including review and understanding of technical documentation and mechanical drawings.

2. Knowledge of quality requirements for medical device manufacturing and

requirements for inspection and testing.

3. Application of risk management and principles of ISO 14971.

4. Understanding of quality management systems for medical devices per ISO 13485

Pre-requisites/Job Experience

1. Bachelor’s degree in engineering or other technical discipline preferred.

2. Minimum 5-10 years in quality control for medical device manufacturing

3. Excellent knowledge of ISO 13485

4. Familiar with modern quality tools such as FMEA, Control Plan, and Statistical techniques

Physical Requirements
1. Moderate lifting.

2. Extended microscope and computer usage.

3. Extended periods of walking or standing.

Quality Engineer I

Develops, implements and maintains procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. Develops and implements systems to improve the detection and prevention of quality failures. Process improvements; analyzes nonconforming product/process/material issues.

Supports Manufacturing/Ops transfer activities, including equipment and process qualifications/validations. Participates in Quality planning- facilities and products: requirements, documentation and completion (overview/monitoring).

Job Responsibilities

1. Perform quality inspections according to written procedures.

2. Assist in the development of new inspection and test methods.

3. Provide feedback to QA, Operations and R&D on quality issues.

4. Assist product development team members in initiating document changes.

5. Integral part of project team to launch new products.

6. Integral part of project team for manufacturing transfer activities, equipment and cleanroom qualifications.

Qualification Requirements Skills
1. Inspection techniques, including technical documentation and mechanical drawings.

2. Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing.

3. Plans, documents (protocol and reporting) product/process validations.

4. Contract review-new customer/new product.

5. Participate in supplier qualification activities and audits.

6. Initiates and/or verifies corrective and preventative actions resulting from NCMR’s, audit findings and customer complaints.

7. Develops and completes qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ, etc.

8. Identify/evaluate quality inspection/test equipment requirements.

9. Lead Quality Circles for process improvement/problem solving.

Pre-requisites/Job Experience

1. Degree in related field or equivalent.

2. 0-2 years in quality control for medical device manufacturing.

3. Use of video inspection equipment (desirable) and other inspection tools.

4. Inspection sampling plans.

Physical Requirements
1. Moderate lifting.

2. Extended microscope and computer usage.

3. Extended periods of walking or standing.