Quality Engineer

Norwalk, OH

$60K-$80K

Permanent

The company are seeking a dedicated Quality Engineer to join their team in Norwalk, OH. This role provides essential support for maintaining compliance with the Quality System, regulatory requirements, and the company’s strategic goals. As a key member of the team, the Quality Engineer will collaborate with new product development, procurement, manufacturing, and product servicing teams to uphold the highest quality standards.

Key Responsibilities:

• Work alongside teams supporting new product development, procurement, manufacturing, and servicing, representing the Quality Engineering discipline.
• Complete Quality Engineering tasks on schedule.
• Promote awareness of quality and regulatory requirements.
• Lead or participate in process and procedure development and improvements.
• Utilize statistical process control (SPC) methods to analyze processes and process changes.
• Develop new solutions to address issues identified during team activities.
• Quality Standards & Compliance: Assist in implementing, maintaining, and ensuring compliance with industry standards such as FDA regulations, ISO 13485, and company policies.
• Provide training on the Quality System and regulatory standards.
• Support the manufacturing line by addressing and resolving quality issues.
• Contribute to metrology and preventive maintenance programs.
• Lead validation and verification strategies for both new and existing products and processes.
• Develop and maintain Master Validation Plans.
• Participate in Corrective and Preventive Action (CAPA) processes as needed.
• Investigate escalated product complaints, ensuring timely root cause analysis and customer response.
• Monitor product and process performance, acting upon trends.
• Lead the Material Review Board (MRB) team to ensure proper disposition of non-conformances.
• Collaborate on the development and approval of key Quality System documentation (change orders, DHF, DMR, DHR, labels, etc.).
• Conduct internal, vendor, and process audits as scheduled.
• Interface with suppliers to resolve quality-related issues.
• Quality Improvements: Drive measurable improvements related to products, processes, and services.
• Take ownership of essential duties and responsibilities to support continuous improvement initiatives.

Qualifications:

• Education: Bachelor’s degree in an Engineering discipline (or equivalent).
• Experience: 3-8 years of relevant experience in process/quality engineering, preferably in the medical device industry.

Technical Knowledge:

• Familiarity with mechanical testing, material properties, and metrology.
• Solid understanding of U.S. FDA QSR, ISO 9001, MDD 93/42, ISO 13485-2003, and Canadian Medical Device Regulations.

Certifications (Preferred, but not required):

• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).

Skills & Competencies:

• Proficiency in statistical analysis and problem-solving tools (e.g., Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PDCA, Pareto Analysis).
• Knowledge of Quality Tools including Quality Planning, TQM, Lean, Six Sigma, and advanced statistical techniques.
• Strong verbal and written communication skills for technical reporting and presentations to management.
• Project Management skills.
• Proficient in Information Technology applications.