- Evaluates suppliers for technical capability and quality system performance. Leads and positively influences product improvements of supplied products through effective use of the Company's quality system.
- Leads the site effort in managing the nonconforming material functions through effective identification, segregation, technical root cause failure analysis and disposition of material. Resulting in sound corrective action at the supplier site to prevent reoccurrence. (SCAR System Administration).
- Actively reviews existing Raw Material Specifications, supplier capability, and the corresponding Receiving Inspection Instructions for accuracy and applicability.
- Supports (including leading as needed) root cause failure investigation activities.
- Writes/edits/approves investigation reports.
- Participates in Complaint Committee meetings and present investigation findings to peers and management.
- Represents the Quality Control department in evaluating failures, performing technical root cause analysis and developing and executing corrective and improvement actions.
- Performs statistical analysis of data from experiments and manufacturing process trend monitoring.
- Attends and actively participates in Management Review Board and presents findings and recommendations.
- Perform other work-related duties as assigned.
- B.S. in Engineering/Chemistry/Biology/Technical Discipline or equivalent combination of certification and work experience.
- 3-5 years' experience in Quality and Manufacturing Systems in Medical Device and high-volume manufacturing environments.
- Problem Solving Methodologies/Process Capability / ISO 13485 / Design of Experiments / Sampling Plans.
- Experiences in providing leadership to technical teams and the use of problem-solving methodologies such as DMAIC, Ishikawa, Kepner / Tregoe etc.
- Strong technical aptitude and experience is a required, level of technical writing skills and abilities.
- Excellent communication: ability to communicate effectively with all levels of employees throughout the organization.
- Able to develop and maintain strong working relationships with internal and external customers.
- Must have a strong understanding of manufacturing and quality systems principles is required.
- Minimum 3 years' experience in Supplier Quality Engineering.
- Supplier Quality skills and experience including auditing, performance management and SCAR management.
- Experience working with injection molding.
- Experience interacting with Regulatory Bodies (FDA, ISO).
- Medical Device Manufacturing experience.
- Knowledge of quality systems and regulations for medical device industry.
- Ability to lead and facilitate a group of technical experts (including suppliers) in root cause investigations.
- Proficient in Microsoft Office, statistical software programs, operating systems, voice and email, etc.
- Advance skills in statistical techniques and methods required.
- ASQ Quality Engineer Certification (CQE).
- With all levels of Manufacturing, on a regular basis on such activities as implementing daily inspection activity, conducting product and system failure analysis, supporting the non-conforming material system, releasing product, reviewing/closing documentation, implementing corrective and preventive action, performing systems assessment/feedback and supporting product/process validations.
- Works closely with Quality Assurance in complaint analysis and provides input to risk-based decisions.
- Works closely with individual buyers will actively manage the supply base through data, analysis, metrics and business reviews. Interacts with all levels in providing technical guidance and support for supplier management, material control and compliance issues, resolving non-conforming materials, and supporting departmental/corporate goals and objectives and process improvements.
- Support as needed supplier nonconformances that result in complaints or other regulatory considerations.
- Collaborates with the engineering staff and management on conducting technical failure analysis to resolve and preclude quality issues, supporting supplier process validations, and supporting departmental/corporate goals and process improvements.
- Vendors and customers.
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Supplier Quality Engineer - Carlsbad, United States - Ortho Clinical Diagnostics
Description
The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
The Role
As we continue to grow as QuidelOrtho, we are seeking a Supplier Quality Engineer. The Supplier Quality Engineer interacts with the Company's suppliers on matters related to product quality. This position maintains and improves the Company's Supplier Management System which includes supplier qualifications, supplier audits, supplier corrective action process and scorecards. Leads complex root cause failure investigations and troubleshooting of customer complaints and product nonconformances within manufacturing. This position will also support incoming inspection in a technical capacity related to inspections. Acts as the champion of Quality System compliance.
This position will be onsite working at our Carlsbad, CA office. There will be 15-20% domestic travel required.
The Responsibilities
The Individual
Required:
Preferred:
The Key Working Relationships
Internal Partners:
External Partners:
The Work Environment
The work environment characteristics are representative of an office, laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of manufacturing goals.
Position requires ability to travel up to 25-30% of the time. Position requires ability to lift up to 20 lbs. on occasion. Up to 50% at desk, on manufacturing floor, walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.
Salary Transparency
The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $92,000 to $156,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
Equal Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at .
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