Sr Quality Engineer - Exempt

The Senior Quality Engineer is responsible for representing the quality engineering function to develop and execute a strategy that organizes, directs, and reports on all supplier quality-related activities for design and manufactured items made for the AST stapling business platform.

Primary Duties

• Focus on supplier selection, qualification, manufacturing, and review of technical quality documentation, including Risk Management Documentation.
• Lead PPAP qualifications with the Client.
• Collaborate with Client to develop robust SCAPAs.
• Support the Quality team in developing and improving an effective Supplier Quality process that supports finished goods product quality globally.
• Collaborate on New Product Development (NPD) teams to evaluate and understand future Client and their associated quality and development plans.
• Build and own the strategy for managing the Client/Suppliers for the business.
• Communicate with the business Quality lead on CM initiatives, updates, and issues.
• Ensure CM compliance with business Quality Systems and all relevant internal procedures and policies.
• Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by Client.
• Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by Client.
• Develop, communicate, and manage a strategy/plan for addressing finished goods Client/Suppliers capability deficiencies.
• Ensure proper approval and documentation practices are followed for any process, material, or tooling change (SCR - Supplier Change Request) at Client.
• Define and manage the process for growing effective "partnerships" with preferred Client to drive optimal performance founded on common interest.
• Lead by Example: Setting continuous-improvement driven mentality and solid quality culture for the organization.
• Maintain compliance to set Key Performance Indicators for the business.
• Manage and report on Client/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 regulations.
• Translate engineering, manufacturing, and quality requirements for CM products.
• Perform deviation investigations into quality issues arising from CM activities.
• Manage qualifications of changes and coordinate associated change control activities.
• Evaluate Client using the appropriate CM performance management processes and develop reports on CM quality performance for company management, recommend and implement the continuous improvement of CM quality systems.
• Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained.
• Participate in annual supplier forums and business reviews.

Technical Skills Required

• Supplier changes (PPAP) expertise.
• Risk management documents.
• Work with new and existing Client/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs.

Education and Experience

• Bachelor's Degree in an Engineering/Scientific/Electronic or technical field.
• Minimum 5 years of experience in a Supplier Quality, Quality Engineering, or Reliability Engineering function.

Work Schedule

Yes, the contractor will be working 40 hours a week. The position requires the candidate to be onsite with some flextime - 3 days in office and 2 remote.

Additional Responsibilities

Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product. 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.

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.
• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
• Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work products.
• Required Knowledge and Experience: 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 5 years of relevant experience, or an advanced degree with a minimum of 4 years of relevant experience.