JOB OVERVIEW:
As a Senior Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the manufacturing facility. The Senior Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal customers and external suppliers. This position reports directly to the Director of Quality Assurance/Regulatory Affairs. The Senior Quality Engineer will play a key role in supporting existing manufacturing processes for the company's medical device product line.

JOB RESPONSIBILITIES AND DUTIES:

• Consistently models the core values of the company both internally and externally.
• Openly commits to and supports company processes and systems.
• Revises/analyzes whether current products and processes (including actions or decisions taken) comply with regulations such as QSRs, ISO 13485, etc., including providing support during internal and external audits.
• Participates in preparation activities for, or interactions with, regulatory agencies (e.g., FDA, notified bodies).
• Actively participates in Management Review & Compliance meetings.
• Responds to internal or external audit observations related to the quality engineering function.
• Properly establishes and maintains required documentation of quality assurance activities and/or quality systems.
• Supervises and supports quality assurance personnel on daily activities.
• Performs periodic line audits to evaluate GMPs, production controls, lot segregation, and process audits. Checks audit results to ensure corrective and preventive actions are adequate.
• Acts as the QA representative for Supplier Quality management activities. Responsible for maintaining supplier controls and performing supplier auditing activities.
• Acts as the QA representative on design projects supporting new product introductions, qualification of new suppliers, and development/approval of new product documentation.
• Works with NPI, manufacturing, process engineering, and manufacturing engineering departments to develop, conduct, and approve product and process validation strategies.
• Directs and attends NCR meetings as a member of MRB.
• Conducts and supports investigations, bounding, documentation, revision, and approval of non-conformities (NCs), preventive and corrective actions (CAPAs), and customer complaints. Escalates quality problems when applicable.
• Acts as delegate for the Quality Director when required.
• Champions continuous improvement through the CAPA system, complaint handling, and KPI analysis.
• Provides support in analyzing products related to customer complaints to determine failure modes.
• Analyzes/checks the effectiveness of preventive and corrective actions.
• Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product.
• Provides support in resolving complex technical problems associated with the manufacturing process.
• Revises, approves, and executes IQ, OQ, and PQ validations.
• Maintains and periodically revises CTQs in the manufacturing process to ensure continuous customer satisfaction.
• Develops, maintains, and checks that measuring methods are appropriate for manufacturing processes.
• Provides support in revising and maintaining FMEAs, quality control plans, process instructions, and other manufacturing documents.
• Develops, interprets, and properly implements process monitoring and control methods consistent with process/product risk level.
• Evaluates and interprets common vs. special cause variation in the manufacturing process and determines the adequacy of current process limits.
• Evaluates the need for risk mitigation techniques given product classification, defect types/frequency/severity, patient risk, process capacity, and process controls; determines the effectiveness of previously implemented improvements.
• Owns the risk assessment process, including realization, documentation, revision, and maintenance of risk assessments (e.g., FMEA) as products/processes change.
• Collates and trends key performance indicator data.
• Performs other related duties as assigned to support efficient organizational operation.
• Carries out additional responsibilities and tasks assigned by management.

Key Metrics: CAPAs, NCRs, SCARs

QUALIFICATIONS / EDUCATION AND EXPERIENCE:

• BS degree in manufacturing engineering, quality engineering, life science, or related field, and a minimum of 5 years of experience within the medical device industry.
• Highly motivated with excellent communication skills and proven ability to work as part of a team.
• Familiarity with Quality System Requirements (QSR), Gage R&R, ISO 13485, IQ/OQ/PQ, CTQ, Production NC, CAPA, regulatory requirements, Verification & Validation, medical device engineering change process, medical device quality management, design controls, and problem-solving methods.
• Quality Certification and/or Lead Auditor Certification are not mandatory but would be an advantage.

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong written and verbal communication.
• Organizational skills.
• Ability to summarize complex issues quickly and make decisions.
• Ability to work under pressure and plan personal workload effectively to prioritize appropriately.

PHYSICAL ACTIVITIES:

• Body Positions: Regularly required sitting, standing, and walking for prolonged periods.
• Body Movements: Full range of body movements, including use of hands/fingers to handle or feel objects, and bending, reaching, lifting, and crouching.
• Vision: Ability to read and see instructions and computer screens.

MENTAL REQUIREMENTS:

• Attention to Detail: Able to focus on small details and ensure accuracy and precision.
• Relational: Able to comfortably connect and work with different personalities inside and outside the company.
• Communication Skills: Able to read and write clearly to communicate effectively with team members and supervisors.

WORKING CONDITIONS:

• Work is generally performed in an office and manufacturing environment.
• May require occasional early morning or late afternoon meetings to support business needs.
• Travel may be required for meetings, training events, conferences, or team meetings, including occasional overnight or weekend travel, domestic and international.
• Extended computer and presentation time.
• Work Hours: Full-time, standard working hours, typically Monday through Friday. Occasional overtime or weekend work may be required to meet deadlines.
• Health and Safety: Strict adherence to health and safety guidelines is required to prevent accidents and ensure a safe working environment. Regular training on safety procedures and emergency protocols is provided.

Pay: $116,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person