Job Description
The role supports key quality and engineering activities such as risk management activities, process and product audits, Engineering and capability studies support, Quality control plan, documentation creation and review and the enforcement of compliance with ISO13845: 2016 and applicable FDA and EU MDR requirements both internally and with critical suppliers including the contract manufacturing organisation (CMO).
Duties and responsibilities
- Ensure compliance with ISO14971 through the Risk Management Plan, Risk Analysis Use FMECA and Process FMECA
- Development of applicable Qualification Plans including size of PQ and sampling size with the CMO.
- Development and maintenance of the Device Master Record (DMR) and ensure completion of DMR prior to design qualification
- Aid and assist Supply Chain quality teams to work with Quality agreements and conduct site visits to ensure project completion and right first-time quality is driven
- Works with Supply Chain quality teams to ensure specifications critical to product quality are fit for purpose and transferred effectively from R&D into operations
- Review of protocols and reports (documentation) regarding verification/validation within a projects concerning changes related to products and/or processes.
- Participate in design review ensuring compliance with applicable standards and regulations
- Support NC investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). Supports Product Change Control.
- Performs internal and supplier audits as required. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
- Execute elements of quality management of suppliers (onboarding, evaluation, SCARs) to support new or existing products
Qualifications
- Degree or equivalent in science, engineering, or related discipline
- Minimum of 5 years of experience in Quality Engineering within an FDA regulated medical device manufacturing environment.
- Strong working knowledge of technical problem solving via Six Sigma type tools to analyse, drive root cause, and solve problems. Experience and knowledge of MINITAB.
- Proven track record in Quality Engineering, support of commercialized products and Post Market Surveillance.
- Strong working knowledge of statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
- Strong working knowledge of Risk Management practices, Corrective and Preventative Actions, and regulatory requirements such as FDA QSR’s, ISO 13485, ISO 14971, EUMDR and Human Factor.
Working conditions
The job does not require the person to work in special working conditions.
Physical requirements
The job is not physically demanding and does not have any specific physical requirements.
