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Sr Quality Engineer
195 McDermott Road No Haven, CT 06473 US
Job Description
Competitive Bid
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.
- Lead PPAP qualifications with the CMs
- Collaborate with CMs 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 CMs/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 CMs and their associated quality and development plans
- Build and own the strategy for managing the CMs/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 CMs 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 CMs
- Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs
- Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.
- Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR – Supplier Change Request) at CMs
- Define and manage the process for growing effective "partnerships" with preferred CMs (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 CMs/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 CMs 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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