Senior Quality Engineer

The Role

As we continue to THRIVE as QuidelOrtho, we are seeking a Senior Quality Engineer. The Senior Quality Engineer is focused on Quality oversight of the manufacturing of in vitro diagnostic medical devices. This position has specialized subject matter expert knowledge of raw material quality, manufacturing processes and Quality Systems and mentors/trains other personnel. The Senior Quality Engineer drives quality-related decisions, with appropriate approval authority (both data-based and risk-assessment based decisions). This position requires a large degree of independent decision making.The position will work to resolve quality issues by ensuring adequate root cause investigations conducted and verifying effectiveness of CAPAs implemented. The position will utilize key Quality Engineering principles, tools, and practices to develop and optimize raw materials, suppliers, process controls and quality system processes and identify opportunities to improve quality and cost that are aligned with the overall business goals and QuidelOrtho' s Quality Policy. The Senior Quality Engineer will collaborate with business partners and suppliers to address quality events/nonconformances to rapidly investigate and disposition material. The individual has accountability to oversee, coordinate and execute all of the required activities for end to end for suppliers and/or the manufacturing quality processes as appropriate. This role will support/lead projects providing quality/SME guidance.This role will author, document, and review quality record documentation. The Senior Quality Engineer will ensure audit readiness programs are effectively implemented within the organization. This includes supporting/leading through various roles such SME, technical data preparation, etc. The work should be performed to ensure compliance with company and regulatory requirements (GMP, ISO, IVDR etc.) along with QuidelOrtho core behaviors. This role develops and maintains effective working relationships with peers and business partners. The Senior Quality Engineer is a problem solver and critical thinker in all aspects of the role while navigating ambiguity and range of medium to high complexity of issues.

This position is in Pompano Beach Florida.

The Responsibilities

• Partners with Operations to evaluate and address supplier related quality events including nonconformances, product dispositions customer complaints, root cause investigations and implement appropriate corrections and/or corrective actions based on risk level.

• Analyzes and monitor key quality metrics and develop action plans to address unfavorable trends.

• Oversees site specific supplier quality activities such as review/approval related to additions/updates to the approved supplier list, evaluation of supplier related non-conformances for Supplier CAPA eligibility, management of Supplier CAPA, evaluation of supplier change notifications for product impact and providing supplier audit support.

• Dispositions raw materials and products in accordance with defined procedure and/or utilizing a risk-based approach.

• Performs containment activities as needed.

• Participates in validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities.

• Provides Quality oversight, review and approval of Change Control activities

• Demonstrates advanced problem-solving skills.

• Identifies and resolves problems in a timely manner.

• Gathers and analyzes information skillfully.

• Develops alternative solutions effectively. Analyzes technical data and proposals.

• Leads the charge on continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce and control variation. Participates in improvement projects.

• Quality engineering representative for site projects, including validations and changes managed through the Change Control process in alignment with Ortho global policies, international law and guidance as well as site specific procedures and requirements.

• Assists in audit preparedness activities for both internal and external audits including back room and/or front room management.

• Proficient communication with both internal and external auditors.

• Authors and/or update standard operating procedures and technical reports.

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor of Science degree in Engineering, Science or related field of study and minimum 5-yrs experience or equivalent combination of experience and education.

• Intermediate Microsoft Office (Word, Excel, PowerPoint, etc.) and statistical tools (e.g. Minitab)

• Experience with establishing sample plans, quality test plans, and summarizing / reporting data analysis.

• Clearly and effectively documents, communicates, and presents technical information.

• Works effectively independently as well with a cross-functional team across Operations, Product Support, Compliance, Regulatory, and Suppliers.

• Demonstrates a high degree of accuracy and attention to details.

• Strong organization and time management skills.

• Analytical and problem-solving skills with an ability to use scientific knowledge and statistical methods to identify and resolve issues.

• Knowledge of current and applicable regulations including ISO13485, 21 CFR Part 820, and IVDR or equivalent experience.

Preferred:

• American Society of Quality (ASQ) Certification

The Key Working Interactions

Internal: Manufacturing, Product Support, Formulations, Engineering, Material Management, Quality Labs, Quality Engineering.

External: Suppliers.

The Work Environment

The work environment characteristics are representative of an office, laboratory and manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Flexible work hours to meet project deadlines.

The Physical Demands

Position requires ability to lift up to 50 lbs., work within restricted areas confined by equipment. Up to 50% of time/work within a low humidity environment and/or extreme cold environment with potential exposure to biological, toxic and corrosive reagents; and up to 50% is required to work within the confinements of a cubical style office, and also within a laboratory setting. Walking, standing and sitting for longs 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. Essential functions are subject to change as other duties may be assigned.

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, its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. A salary range for this position is $95,000 to $115,000.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 Employment 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 their 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 recruiting@quidelortho.com.

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