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Job Title: Senior Quality Assurance Engineer

Job Description

We are seeking a dedicated Sr. Engineer in Quality Assurance Engineering to join our team as an individual contributor. This role involves close collaboration with Operations and business functions to ensure the quality performance of products and processes.

Responsibilities

• Work closely with Operations and business functions to ensure quality performance of products and processes.

• Collaborate with internal cross-functional and supplier teams to address top quality issues.

• Manage identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action (CAPA) records within the electronic management system, TrackWise.

• Support the execution and analysis of manufacturing-related complaint investigations and product field actions.

• Investigate and disposition internal non-conforming products within MRB, issuing NCs as appropriate.

• Communicate and collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.

• Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-functional teams for assessment and approval.

• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.

• Collaborate with stakeholders to identify and execute opportunities for supplier part certification.

• Engage in the development and improvement of internal manufacturing and distribution processes for existing products.

• Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

• Participate in and potentially lead the creation and/or review of new or modified procedures.

• Support the development and review of process and equipment validation/qualification and Measurement System Analysis (MSA) of internal processes.

• Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary.

• Perform other related duties as assigned.

Essential Skills

• Bachelor's degree in Science/Technical field or related field.

• Minimum of 3 years of experience in Operations/Manufacturing.

• Experience with CAPA and TrackWise.

• Proficiency in ERP systems and MS Suite.

• Strong multi-tasking, communication, and problem-solving skills.

Additional Skills & Qualifications

• Knowledge of Power BI is a plus.

• Quality experience with CQE and/or Lean Six Sigma Green Belt (LSSGB) certification.

• Experience in the medical device industry with an understanding of US and International Medical Device Regulations.

• Familiarity with GDP, GMP, and experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).

• Knowledge of key Quality concepts such as Risk Management, CAPA, Audits, and Statistics.

• Strong project management, leadership, and influencing skills.

• Ability to manage multiple tasks simultaneously and complete projects in a matrix organization.

• Excellent interpersonal, written communication, oral communication, and negotiation skills.

• Highly developed critical, problem-solving, analytical, and innovative thinking skills.

• Ability to work in a fast-paced, dynamic, and time-critical manufacturing environment.

• Computer literacy in Excel, Databases, ERP Systems, TrackWise, and Statistical software packages.

Work Environment

This position operates in a fast-paced, dynamic, and time-critical manufacturing environment. The role requires collaboration with cross-functional teams and suppliers, managing quality processes, and ensuring compliance with regulatory standards. The work may involve interacting with various stakeholders, including regulatory agencies, and requires proficiency in various software systems and tools.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.