Sr Operations Quality Engineer

LightningCath Inc; Brooklyn Park (MN); On-site; USD 105,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) Plan with company match

Paid Time Off

Parental Leave

Paid Holidays

Job summary

LightningCath Inc. is seeking a Senior Operations Quality Engineer to partner with design and manufacturing teams to ensure QMS-based quality throughout product development and production.

The role emphasizes design control, process validation, CAPA, NCMR, and supplier quality, with additional responsibilities for FAI, training, and equipment coordination in a medical device environment.

Qualifications

• Experience with Quality System Regulations (QSR) and ISO 13485.
• Experience in medical device QA, including DR/verification testing and sterilization validation.
• Strong problem-solving and data analysis skills.
• Knowledge of CAPA, NCMR processes and change control.

Responsibilities

• Serve as quality representative for engineering projects.
• Ensure product development and changes comply with QSR/ISO 13485.
• Lead NCMR and CAPA investigations and reports; collaborate with suppliers.
• Participate in cross-functional reviews of nonconforming products.
• Prepare and review technical documentation with accuracy and completeness.
• Contribute to test plans for DV/VPV and PV/PP testing.
• Provide guidance on sampling and statistical analysis for testing.
• Participate in complaint investigations and ensure proper documentation.
• Train teams on Quality Policies, procedures and design controls.
• Coordinate equipment management and related activities.

Skills

Quality systems

Regulatory knowledge

Risk management

Design controls

Statistical analysis

CAPA

NCMR

FMEA PFMEA

Documentation

Cross-functional teamwork

Independent work

Education

B.S. degree in Science, Engineering or Technology

Job description

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.