Sr Quality Engineer - Exempt

We are seeking a highly skilled and experienced professional to join our team. The successful candidate will possess the following top technical skills:

• Root Cause Analysis (RCA): Expertise 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.

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; OR 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

• Regulatory Standards & Compliance: ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, Good Manufacturing Practices (GMP)
• Risk Management & Validation: Risk Management methodologies, 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 such as Design History Files (DHF) and Device Master Records (DMR)
• 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), conducting thorough product investigations and failure analysis, and implementing corrective actions

Additional Competencies

• Strong analytical and problem-solving skills with a focus on continuous improvement
• Proficiency in quality tools such as Six Sigma, Lean Manufacturing principles, and statistical analysis software (e.g., Minitab)

Work Schedule

This position requires a commitment of at least 40 hours a week, and the candidate must be onsite 100% of the time.

Interview Timeline

Interviews will begin as soon as possible, with adjustments made as needed to accommodate scheduling.

Product Line Support

This candidate will support Cardiovascular Products such as Arterial Cannulae and Revascularization Products.

Responsibilities

Responsibilities may include developing, modifying, applying, and maintaining quality standards and protocols for processing materials into partially finished or finished materials products. Collaborating with engineering and manufacturing functions to ensure quality standards are in place. Designing and implementing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

Ensuring that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. Specializing in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Qualifications

Requires advanced knowledge of the job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.