Quality Engineer, Acute Innovations - Medical Device

A Quality Engineer 3 is responsible for quality planning and the overall quality of new products being released to the market, and managing sustaining product quality and compliance to medical device manufacturing. This role actively participates in product development activities, ensuring product and process conformance to global standards (including FDA and ISO 13485). The purpose of this position is to serve as a resource to product development and manufacturing to improve product quality, reliability, and process capability and facilitate teams in identifying, documenting, assessing, correcting and presenting quality issues using risk analysis and root cause analysis tools. The QE supports the Quality and Regulatory Manager with integration of quality system requirements, ensuring compliance with relevant global medical device regulations and standards.

Duties/Responsibilities
• Provides quality and NPI leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development.
• Provides support to development and engineering functions for validation planning and transfer activities. Assists teams in determining validation needs and requirements.
• Collaborates with project teams to ensure understanding of and compliance with regulations, procedures, and requirements. Provides training, guidance and interpretation as needed.
• Leads NPI efforts by liaising between design and manufacturing to observe, communicate, and solve DFM (design for manufacturability) concerns.
• Assists and develops internal and external verification requirements aligned to a risk and process capability based approach.
• Leads and participates in continuous improvement activities across all departments.
• Assists with supplier quality management alongside Quality Manager; develops supplier agreements, initiates SCAR's, PIP's, site and desk audits, and regular performance evaluations.
• Ensures quality and completeness of project design history files, validation packages, and change orders.
• Provides ongoing quality engineering support throughout the product life cycle, including CAPA investigations, and design changes.
• Enhances and drives product risk management activities. Ensures identified activities and mitigations are executed as agreed.
• Becomes familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making; coordinates issue resolution using a risk-based approach.
• Reviews verification and validation reports and identifies gaps for cGMP compliance. Develops and executes strategies to close gaps in an efficient, technical, and compliant manner.
• Ensures product development and validation programs meet requirements of FDA and ISO.

Qualifications
• Bachelor's degree in an engineering or science discipline; advanced degree preferred
• 5-10 years of experience in quality assurance in a regulated environment. Direct experience working with implantable devices preferred.
• Three - 5 years of experience applying quality regulations and standards (e.g. 21CFR 820, ISO 13485, ISO 14971, Medical Device Directive, etc.)
• Experience with CAPA and failure investigation tools and techniques.
• Applied experience with quality and statistical analysis tools (e.g. SPC, 6 Sigma, Risk Analysis, FMEA, DOE, trend analysis, etc.)
• Highly effective communicator, able to take action even when a position may be unpopular. Able to facilitate difficult conversations and negotiate solutions among different department representatives.
• Proven track record of strong team work and delivering results. Adaptable to fast-paced, dynamic work environment with shifting demands.
• Working knowledge of Microsoft Office. Expert at Microsoft Excel.
• ASQ Certified Quality Engineer preferred.


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