Systems Quality Engineer

Our client a leading Medical Device Manufacturer with over 30 years of outstanding operational performance and customer services are looking to attract a Systems Quality Engineer for their Business. This is an FDA registered facility that is also certified to ISO 13485:2016 for the manufacture of high-quality PCBAs, subassemblies and complete devices up to and including Class III medical devices.

Objectives:

• Supports FDA’s Quality System Regulations, ISO 9000, ISO 13485 as well as all international standards relevant to customer products for the manufacturing facility.
• Own Event Investigation process and support CAPA system compliance ensuring timely closure of all Customer investigations.
• Support all product and process audits as per procedures.
• Responsibility for Corporate SOP alignment and compliance ensuring all Site documents are kept aligned and completed on time & interact and support Regulatory Compliance officer in key tasks.
• Support Quality Leadership team in Key site projects and support critical Customer issues and investigations.
• Interact with regulatory agencies and assume a key role in supporting all Audit streams.
• Work across and support key Quality Department areas such as Customer Quality Engineering, Supplier Quality Engineering and relevant QMS activities such as Internal Audit program, Performance excellence, Management review, Business Continuity Management, Key Quality Projects working with Lean Six Sigma and Operations excellence lead.
• Support right first time introduction of any new products or processes introduced in the site.

Responsibilities:

• Must write standard operating procedures as well as regulatory standard responses in Event investigations.
• Make training presentations to internal employees at all levels as required.
• Support QMS lead in CAPA System and compliance.
• Support of internal audits and inputs to Management Review.
• Monitoring of processes, ensuring compliance to all relevant procedures and housekeeping is maintained
• Support Quality leadership team where appropriate to improve Quality Systems and drive projects to support these Departments.
• Other duties and responsibilities as itemized by the Head of Quality.

Quality:

Assure ongoing compliance with quality and industry regulatory requirements

Health & Safety:

Ensure compliance with Health & Safety Legislation and Regulations.

Measurements:

• On Time Closure of Event Investigations and any CAPA activity and general updates such as Control plans, FMEA, SOP related updates.
• Support Internal Audit Plan and on-time Execution
• Target Zero Non conformances and observations on External and Customer Audits
• On time closure of projects.
• On time review and alignment of site SOPs to Corporate SOP updates.
• On time close out of Management review and associated follow up on all MR actions.

Mandatory:

• Minimum NFQ Level 8 Degree in Quality related discipline including extensive knowledge of Regulatory compliance and standards.
• ISO Lead Auditor training and extensive auditing experience
• A minimum of (5) years in quality assurance / regulatory affairs experience with emphasis in a medical device industry
• Good knowledge of current FDA Quality Systems Regulation, ISO 9000, ISO 13485, and MDSAP.

Skills:

- Good interpersonal, writing and leadership skills.

- Must be a strong communicator and ability to multi-task and support areas where workload is heavy.

- Ability to create a team environment and assist all teams in problem solving.

- Ability to work independently and resolve any regulatory & site Quality investigations as they arise.

- Strong audit capability.

- Ability to read, analyze and interpret quality metrics, Corporate SOPs, Site SOPs and Customer Quality agreements and any associated legal documents during Customer engagement.

- Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.

- Ability to effectively present information to customer and internal personnel at all levels.

Desirable:

• FDA audit experience highly preferred.
• Computer Skills: MS Word, Excel, , MS Project.
• Agile, Oracle tool knowledge.
• Lean Six sigma Green belt certified.