Search Jobs

Controls Engineer (2)
Project Engineer (2)
(2) Design Quality Assurance Engineer (1)
*2* Product Coordinators (1)
AP Specialist (1)
Assembler, Lead (PERM) (1)
Associate Scientist I - 8933310 (1)
Associate Technical Lead, Software Development (Temp-To-Perm) (1)
Audio/Visual Systems Field Engineer (PERM) (1)
AutoCAD Tech (Temp-To-Perm) (1)
Benefits Coordinator (PERM) (1)
Bill Pay Specialist (PERM) (1)
Biotech Recruiter - 284 (1)
Business Objects Report Developer - 9047082 (1)
Business Systems Analyst - 9056306 (1)
Buyer (1)
Change Management Consultant - R1010061.01 (1)
Change Manager (1)
Clinical Systems Analyst - 8949630 (1)
Coding Quality Coordinator (1)
Coding Specialist (1)
Communication Specialist, IT 8856935 (1)
Compliance Engineer (1)
Construction Supervisor (1)
Contracts Paralegal - 9025308 (1)
Controller (1)
Coupa & Oracle EBS Consultant - R1010139.01 (1)
Customer Care - Data Entry specialist (1)
Data Analyst, Business Intelligence (Temp-to-Perm) (1)
Data Architect, Insight Services (Temp-to-Perm) (1)
Data Intelligence Analyst (Temp-to-Perm) (1)
Demand Planner  - 8942321 (1)
Digital Project Manager - 9167086 (1)
Director of Supply Chain (1)
EDI Developer (1)
Electrical Design Engineer (X3) (1)
Electrical Engineer (1)
Electrical Engineer (PERM) (1)
Electrical Engineering Contractor - 283 (1)
Estimator (1)
Experience Design Researcher (1)
Financial Analyst (PERM) (1)
Financial Analyst - 8722454 (1)
Full Stack Engineer (1)
HR Learning & Development Project Coordinator - 8795069 (1)
Human Resources Generalist (1)
Human Resources Manager (1)
Integration Analyst (Temp-To-Perm) (1)
JavaScript - Software Engineer - R1010113.01 (1)
Manager, Clinical Data Management - 8882215 (1)
Manufacturing Engineer - 178 (1)
Mechanical Engineer, Operations - 9163986 (1)
Mechanical Engineering Project Manager (1)
Oracle Cloud Financials Business Analyst - R1010117 (1)
Oracle HCM Cloud Functional Analyst - 9148368 (1)
Oracle HCM Cloud HR Team Lead - R1010141.01 (1)
Partner Operations Technical Writer - 9024908 (1)
Principal Software Engineer, Cloud Platform & Infrastructure (PERM) (1)
Product Manager (1)
Product Senior Technical Writer - 9150998 (1)
Production Supervisor (2nd Shift) (1)
Program Manager (1)
Project Manager - Customer Care - 9057803 (1)
PropertyManager / Account Manager - Clean Room (PERM) (1)
Quality Assurance Specialist III (1)
Quality Control Engineer (1)
Quality Engineering Manager I (PERM) (1)
Report Developer II, Business Intelligence (Temp-to-Perm) (1)
Retail MDM Architect - R1010010.01 (1)
Sales Recruiter - 9161468 (1)
SAP SD Tester - R1010081.01 (1)
SAP Treasury Management Team Lead - R1010120.01 (1)
Scrum Master (PERM) (1)
Security Solutions Engineer - Post Sales (PERM) (1)
Senior Applications Analyst (PERM) (1)
Senior Architect, Software Development (Temp-to-Perm) (1)
Senior Coding Analyst (1)
Senior Coordinator, Operations & Facilities (PERM) (1)
Senior Maintenance Electrician (1)
Senior Manufacturing Engineer (1)
Senior Manufacturing Engineer (PERM) (1)
Senior Systems Engineer (PERM) (1)
Senior U/X Designer, Mobile (PERM) (1)
SOA Developer (porting Android to iOS) - R1010012.01 (1)
Software Architect - R1010136.01 (1)
Software Developer - 8940270 (1)
Software Engineer, Development Engineering (1)
Software Test Engineer - 9056021 (1)
Software Test Engineer I - 8923762 (1)
Software Test Engineer I - 9059561 (1)
SQL Server BI report Developer (1)
Sr. Accounting Specialist - 9166010 (1)
Sr. Backend Engineer (Java) - 9158715 (1)
Sr. BIM Design Engineer (1)
Sr. Financial Analyst - 9049841 (1)
Sr. HelpDesk Analyst (1)
Sr. Mechanical Engineer - 239 (1)
Sr. SEC Reporting Analyst - 9022843 (1)
Staffing Coordinator - 9061182 (1)
Systems Architect - R1010076.01 (1)
Talent Acquisition Coordinator - 9043069 (1)
Talent Acquisition Recruiter - 8923526 (1)
Team Lead - AIX Administrator - R1010130.01 (1)
Technical Support Engineer (1)
Technical Support Representative (1)
Technical Writer, GxP Digital Quality Systems (1)
Tradeshow & Events Specialist (1)
Upstream Principal Scientist-MS&T - 8907358 (1)
User Interface Developer IV - 8889897 (1)
Website Operations Manager - 9064914 (1)
« Return to Jobs

(2) Design Quality Assurance Engineer

Location: Natick, Massachusetts

Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:


Date Posted: 4/5/2019

Hiring Organization: Connexion Systems & Engineering

Job Title: Design Quality Assurance Engineer  

Industry: Medical Device                

Location: Waltham, MA 02454

Employment Type: Full Time, Permanent   

Pay Range: 100-110K

Duration: Permanent



Design Quality Assurance Engineer – Medical Device


The Sr./ DQA Engineer is responsible to lead Design Quality Assurance activities in New Product Development and Sustaining efforts across the company.

The Senior Design Quality Assurance Engineer is responsible to lead Design Quality Assurance activities in support of Product Development and Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, approval of test methods, design and process verification and validation test plans and reports. You will play an important role in reviewing and approving design changes and in developing/ improving risk-based product controls.

In the position you will be the contact person for quality related issues for R&D. Additionally, you will closely work together with QA-colleagues, R&D, project leads and production. You will issue QA documents with sponsors, review the analytical methods/ results, production records, and qualification as well as validation protocols and reports and participate in other QA tasks as needed.


  • Responsible for Review and Approval of protocols and reports, SOPs and Master Documents pertaining to Research and Development activities and its compliance.
  • Responsible to provide Quality support at various stages of Product Development.
  • Responsible for the co-ordination with internal and external customer and R&D team to resolve Development related product quality issues.
  • Responsible for review of Product Development Reports and relevant data.
  • Coordinate and support for release of Pilot batches for studies.
  • Ensure FDA and other regulatory knowledge and experience is applied to risk assessments
  • Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
  • Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs (Design Control, CAPA, etc.), ISO 13485 and other national and international quality and regulatory requirements and standards
  • Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
  • Develop statistically sound sampling plans and perform data analysis
  • Understand and help implement global processes of the QMS related to Design Controls
  • Work with product development teams and other QEs to assure compliance to the QMS
  • Analyze complaint data, post market surveillance and risk analysis to assist in the identification of potential product improvements based on sound engineering principles.
  • Lead Corrective and Preventive Actions (CAPA) and QMS continuous improvement projects as they relate to Design Assurance and Complaint Review Board Process


  • Bachelor’s degree in Engineering or related field, plus a minimum of 5 years of related experience in the medical device or another regulated industry
  • Expert understanding of appropriate global medical device regulations, requirements and standards, including Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820) is a must
  • Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change movement
  • Ability to analyze information and come to conclusions based on presented data
  • Ability to communicate effectively both orally and in writing
  • Self-motivated and ability to manage time working on multiple projects simultaneously
  • Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems, ServiceMax and Agile is a plus

Must be able to communicate appropriately and adequately to all management levels, including group presentation experience



When responding to this job posting you MUST include the Job# and Job Title in your subject line.


Contact Info:                                                                                                                                             


ConneXion Systems & Engineering

490 Boston Post Road

Sudbury, MA 01776