Quality Assurance Engineer/Medical Device

QUALITY Assurance Engineer
6 months contract in Totowa, NJ

DESCRIPTION:
The Quality Assurance Engineer is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. The Quality Assurance Engineer is responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.

KEY RESPONSIBILITIES INCLUDE:

- Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site.
- Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc.
- Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of simple yet detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts.
- Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
- Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc.
- Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
- Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
- Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

QUALIFICATIONS:
1. Bachelor's degree plus 4 years working experience in Quality Engineering or Quality Assurance Management.
2. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR and ISO 13485.
3. Demonstrated understanding of product development life cycles, design change and document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
4. Significant Multi-Modality Sites: Minimum 4 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
5. Small and Simple Sites: Minimum 3 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
6. Demonstrated experience using word processing, spreadsheet, and presentation software.
7. Demonstrated understanding of continuous quality/process improvement tools:
(As defined by the local site, eg DMIAC, SPC, Lean SS, 5S,)
8. Ability to communicate using English (or local language)

NOTE:
We need a candidate with strong medical device Design Controls/CAPA experience to fill the gap on my team, this is a MUST have. MUST HAVE RECENT EXPERIENCE IN A FAST PACED MEDICAL DEVICE MANUFACTURING ENVIRONMENT NO PHARMA. Key for this Quality Engineer position is experience with Manufacturing Support, FDA regs. knowledge and experience with ISO-13485, familiarity with CAPA. The qualified candidate must have a 4 year degree preferably Quality or related technical degree, mid-career (5-7 years exp), great attention to detail, ability to work in a FAST PACED environment, MUST HAVE CURRENT experience in the medical industry. CQE or CQA certifications are highly desired. This is a 1st shift position with typical hours of 8am - 5pm Monday - Friday, the preference is for a local candidate and interviews will be onsite.