Senior Quality Engineer

Top 3 technical skills that are required for the role:

Root Cause Analysis (RCA): Skills in identifying and resolving issues using tools like 5 Whys, Ishikawa diagrams, and corrective/preventive actions (CAPA).

Risk Management: Strong understanding of risk analysis tools like FMEA (Failure Modes and Effects Analysis) and fault tree analysis to mitigate product and process risks.

Quality Management Systems (QMS): Expertise in managing and implementing QMS, including ISO 13485 and FDA regulations specific to medical devices.

Years’ Experience Required:

Education & Experience:

Master’s degree in industrial engineering or a related engineering field with at least three (3) years of experience as a Quality Engineer or in a related role.

Bachelor’s degree in industrial engineering or a related engineering field with at least five (5) years of experience as a Quality Engineer or in a related role.

Required Technical Expertise (Minimum 3 years of experience in each of the following areas):

Regulatory Standards & Compliance:

ISO 13485 (Quality Management Systems for Medical Devices)

ISO 14971 (Application of Risk Management to Medical Devices)

21 CFR Part 820 (Quality System Regulation for Medical Devices)

21 CFR Part 11 (Electronic Records and Signatures)

Good Manufacturing Practices (GMP)

Risk Management & Validation:

Risk Management methodologies, including risk assessment and mitigation strategies.

Test Method Validation (TMV)

Design Validation and Verification Processes

Process Validation (IQ/OQ/PQ)

Documentation & Records Management:

Proficient in creating, maintaining, and managing essential documentation, including Design History Files (DHF) and Device Master Records (DMR), in compliance with regulatory requirements.

Excellent Technical Writing Skills:

Ability to produce clear, concise, and detailed documentation for validation reports, risk management files, work instructions, and regulatory submissions.

Nonconformance & Product Investigations:

Skilled in managing and resolving Non-Conformance Material Reports (NCMRs) to ensure timely and effective disposition of nonconforming materials.

Experienced in conducting thorough product investigations and failure analysis to identify root causes and recommend corrective actions.

Proficient in product investigation and containment by implementing and enhancing in-place processes to mitigate risks and maintain product quality.

Extensive experience in performing Root Cause Analysis (RCA) to uncover underlying issues and drive the implementation of Corrective and Preventive Actions (CAPA) for sustained improvements.

Additional Competencies:

Strong analytical and problem-solving skills with a focus on continuous improvement.

Excellent communication and technical writing skills for clear and concise documentation.

Proficiency in quality tools such as Six Sigma, Lean Manufacturing principles, and statistical analysis software (e.g., Minitab).

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, this person will work at least 40 hours a week.

Does this position require the candidate to be on-site or remote? If hybrid, what does the onsite vs remote schedule look like? The candidate must be 100% of the time onsite.

What is your timeline for scheduling interviews? The plan is to start interviewing candidates as soon as possible, making any adjustments needed on my calendar.

What product line will this person support? This candidate will support Cardiovascular Products such as Arterial Cannulae and Revascularization Products.

Responsibilities may include the following, with additional duties assigned as needed.

Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials products.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

May specialize in areas such as design, incoming materials, production control, product evaluation and reliability, inventory control, and/or research and development, as they apply to product or process quality.