Sr Quality Engineer - Exempt

Must Have:
2-5 Years Experience in Supplier Quality with BS in Engineering
conducing PPAPs

JOB DESCRIPTION
The Senior Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize, direct, and report on all supplier quality-related activities for design and manufactured items made for the AST stapling business platform.
Primary duties are focused on matter pertaining to supplier selection, qualification, manufacturing, and review of technical quality documentation that includes Risk Management Documentation.
Top 3 technical skills that are required for this role:
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 Required:
Bachelor's Degree in an Engineering/Scientific/Electronic or technical field
Years' Experience Required:
Minimum 5 years experience in a Supplier Quality, Quality Engineering or Reliability Engineering function.
Will the contractor be working 40 hours a week? If not, weekly estimate?
Yes
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like?
Onsite (with some flextime - 3 days in office and 2 Remote)
What is your timeline for scheduling interviews?
July 1st
What product line will this person support?
AST - Stapling platform
Additional responsibilities details:
Lead PPAP qualifications with the Client
Collaborate with Client to develop robust SCAPAs
Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.
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
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
Partner with Supplier Quality Managers to build a strategy for managing the Client in all regions
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, etc.
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 and which demonstrate trust, loyalty and financial success
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
Maintain the highest level of compliance and operational standards set by 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 co-ordinates 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

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. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. 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 and 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 indepth 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 objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of 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 minimum of 5 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.