Staff Quality Engineer

Summary :

The Staff Quality Engineer leads and oversees the design changes for sustaining and new production introduction for the iovera medical device portfolio, championing key design change projects in alignment with the Company’s overall direction and medical device needs.

Essential Duties & Responsibilities :

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job.

Other duties may be assigned.

• Ensure that all modifications to product designs meet regulatory and quality standards through thorough risk assessment, validation and verification processes.
• Partner with R&D on new product development through project phases, providing input on process quality requirements.
• Collaborate closely with cross-functional teams to implement design changes, ensuring compliance with industry regulations and internal quality management systems.
• Implement a risk-based remediation strategy and execute a detailed plan to address any identified gaps to ensure compliance with regulations and quality policies in all relevant markets.
• Help foster a culture of excellence, professional integrity and respect for patient safety. Ensure that all necessary management systems are in place to make these high principles actionable.
• Support the Product Reliability Program or complaint investigations as needed. Assess data, support reliability strategy and initiatives, support complaint investigations, record results and summarize findings in quality records.
• When necessary, support teams interacting with FDA / Notified Bodies / Foreign Regulatory agencies to address and resolve issues.

Work with cross-functional teams in preparation of regulatory filings, including 510(k) notifications, IDE correspondence, Technical Dossiers, etc.

Internally partner with the operations group, proactively assessing and recommending continuous process and quality improvement.

Trend and report quality metrics.

• Lead / own or support CAPA investigations and CAPA closures.
• Support internal and external audits to ensure compliance with all quality standards. Partner cross functionally to initiate corrective actions and drive root cause analysis and resolution of issues through team members and suppliers as necessary.
• Travel may be required.

Supervisory Responsibilities :

This role has no supervisory responsibilities.

Interaction :

The incumbent works closely with various departments (., QC, QA, Operations, regulatory and within R&D).

Education and Experience :

• BS Degree or higher in life sciences, biomedical, quality or similar engineering field requiredElectrical Engineering and Software knowledge preferred
• 8 years’ experience in medical device design or like fields required

Knowledge, Skills, and Abilities :

• A practical and working knowledge of ISO 13485, 21 CFR 820, MDR, ISO 14971, IEC 60601-1 and 2, IEC 62304
• Experience with Design Controls, Product Development, Supplier Audits, Remediation
• Detail oriented, well organized and have excellent communication skills
• Able to manage high workload independently
• Data drive- data analysis and decision making
• Work well with cross-functional team and all levels of the organization
• Able to accomplish objectives with minimal supervision

Physical Demands :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Duties of this job may involve standing and / or walking, but for most part sitting for extended periods of time. Duties also involve daily keyboard data entry.

Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.

Will need to lift and move boxes of paper and binders weighing up to 20 pounds.

Work Environment :

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Typical office setting with a laboratory, offices, warehouse, and cubicles. Noise level is moderate with consistent printer, telephone ringing and conversation.

The base pay range for this role in California is $112,000 per year to $154,000 per year. The range is what we reasonably expect to pay for this role.

The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to : geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.

Benefits :

Medical, Prescription, Dental, Vision Coverage

Flexible Spending Account & Health Savings Account with Company match

Employee Assistance Program

Mental Health Resources

Disability Coverage

Life insurance

Critical Illness and Accident Insurance

Legal and Identity Theft Protection

Pet Insurance

Fertility and Maternity Assistance

401(k) with company match

Flexible Time Off (FTO) and 11 paid holidays

Paid Parental Leave