Sr Operations Quality Engineer

Description

Summary:

The Senior Operations Quality Engineer supports the Quality Management System (QMS) organization by partnering with design and manufacturing teams to deliver operations quality activities. The role applies core quality engineering disciplines, including design control, process control, risk management, supplier quality, root cause analysis, statistical analysis, and continuous improvement, to ensure that products meet design and performance requirements and comply with applicable regulatory, customer, and internal standards. Experience in related technical areas, such as verification testing and sterilization validation, is desired. Day to day, the role contributes to equipment management, First Article Inspections (FAI), CAPA, NCMR, change order review, and training.

Essential Duties and Responsibilities (but are not limited to):

• Function as the operation’s quality representative during the execution of engineering projects.
• Responsible for ensuring product development projects and changes to existing products are conducted in compliance with the Quality System Regulations.
• NCMR and CAPA investigation and reports including assisting in trouble shooting manufacturing problems and ensuring requirement compliance. Collaborate with suppliers on NCMRs and supplier CAPAs.
• Participate in cross-functional teams for the review and disposition of nonconforming products or components.
• Prepare and review documentation with a high degree of accuracy, completeness, and effectiveness.
• Participate in the development of Design Verification and Validation test plans / protocols and Process Verification and Validation test plans / protocols. Provide guidance on Product Requirements compliance.
• Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.
• Participate in complaint investigation. Ensure investigations are thoroughly documented.
• Provide direction to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods, and design controls), when necessary.
• Assist in training of Special Work Orders, Receiving Inspection Processes, and FAIs as required
• Assist in the preliminary DCR and Deviation reviews within Grand Avenue Software.
• Function as the equipment coordinator to manage equipment and ensure equipment related activities are completed according to schedule.
• Other duties as assigned.

Requirements

Technical Skills:

• Working knowledge of medical device regulations (FDA 21CFR820, ISO 13485, ISO 14971).
• Working knowledge of new product design and development in medical devices.
• Working knowledge of the application of risk management, including PFMEA.
• Knowledge of manufacturing operations, process verification and validation, and geometric design and tolerance (GD&T) includes the ability to read and understand prints and specifications.

Conceptual Skills:

• Creative problem solver coupled with good judgement.
• Independent work skills.
• High attention to detail and accuracy.
• Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules.
• Positive, flexible outlook.
• Dependable.
• Excellent organizational and interpersonal skills working in cross-functional teams.

Education/Experience:

• B.S. degree in Science, Engineering or Technology or associated fields, or equivalent combination of education and experience may be considered.
• 5+ years’ experience in Quality Assurance, including quality systems, standards, metrics, and tools.
• 5+ years’ experience in the medical device industry.

Summary of Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan).
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Short Term Disability (STD).
• 401(k) Plan with company match
• Paid Time Off
• Paid Parental Leave
• Paid Holidays
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

• The typical base pay range for this role is between $105,000-130,000/year. Actual compensation will be based on individual job-related knowledge, skills, expertise, and experience.