Quality Engineer

DEKA Research and Development; Town of Berwick; On-site; CAD 60,000 - 90,000; Full time

Job summary

Join a forward-thinking company that is at the forefront of innovation in medical device research and development. As a Quality Engineer, you will play a crucial role in ensuring compliance with industry standards and regulations, driving system improvements, and leading investigations to enhance product quality. This dynamic environment offers the opportunity to work alongside talented professionals dedicated to creating life-changing products. If you are passionate about quality assurance and eager to make an impact in a fast-paced setting, this position is perfect for you.

Qualifications

• 2-5 years of experience as a Quality Engineer in a regulated environment.
• Experience with ISO standards such as 13485 and 14971.

Responsibilities

• Lead investigations and coordinate teams for effective problem resolution.
• Ensure compliance with regulations and prepare detailed work plans.

Skills

Root Cause Analysis

Data Analysis

Problem Solving

Risk Management

Regulatory Compliance

Education

Bachelor's degree in Engineering or related STEM discipline

Tools

FMEAs

Validation Plans

Job description

DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality Manager. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment.

How you will make an impact:

• Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485
• Participate in and lead Risk Management activities in accordance with ISO 14971
• The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation.
• Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills.
• Coordinate the efforts of individuals and teams performing investigations.
• Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cause Analysis and CAPA.
• Use experience with engineering and technology to identify and ensure compliance with applicable standards and regulations.
• Ensure the accurate documentation / recording of information to be used in communication with partners and regulatory bodies.
• Prepare detailed work plans and procedures such as Validation Plans.
• Evaluate and approve proposed design or manufacturing process change.
• Drive system and process improvements.
• Provide reliability and statistical analysis.
• Participate in internal and external audits.

How you will be successful in this role:

• Bachelor's degree in an engineering or related STEM discipline. Additional training and experience may be considered in lieu of degree.
• Minimum 2-5 yrs. of experience as QE in a regulated manufacturing environment.
• Experience with compliance, with applicable standards and regulations such as 21 CFR 820, ISO 13485, and ISO 14971 is preferred.
• Ability to:
  • Multitask and carry tasks through to completion.
  • Manage multiple sources of data and develop reports.

About DEKA:

One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.