Senior Quality Specialist

Abbott; Alameda (CA); On-site; USD 86,000 - 174,000; Full time

Job summary

An established industry player is seeking a dedicated professional to join their Lingo Division in Alameda. In this role, you will lead projects aimed at improving healthcare technology, ensuring compliance with regulatory standards, and enhancing product quality. You'll be part of a dynamic team that fosters innovation and collaboration, backed by a company renowned for its commitment to employee growth and diversity. This position offers a unique opportunity to contribute to life-changing technologies while advancing your career in a supportive environment. If you're passionate about making a difference in healthcare, this is the perfect opportunity for you.

Benefits

Free medical coverage

Retirement savings plan

Tuition reimbursement

Student debt program

Education benefits

Career development opportunities

Qualifications

• 5 years of experience in Quality, Compliance, or Engineering in regulated environments.
• Knowledge of US and non-US Quality System Requirements.

Responsibilities

• Lead projects to resolve complex issues and ensure regulatory compliance.
• Write Medical Device Reports and ensure timely communication with authorities.

Skills

Problem-solving skills

Quality management techniques

Regulatory compliance knowledge

Interpersonal skills

Project management skills

Education

Bachelor’s Degree

Tools

Databases

Computer software

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Alameda, CA location in the Lingo Division. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

What You’ll Work On

• Independently lead groups and projects to resolve complex issues, analyze complex problems and identify their impact, establish probabilities, and draw conclusions reflecting broad business needs.
• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Establish regulatory reportability decisions using event investigation and regulatory decision models.
• Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to end-use customers or regulatory bodies.
• Cross-functionally lead alignment between departments and/or divisions which may include complaint handling, customer service, medical events, and product quality.
• Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation, product development/clinical research, design control activities, complaints, and post-market surveillance.
• Work may require collaboration with other Division sites and/or other Abbott divisions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.
• Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high-risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
• Drives functional performance that ensures cross-functional standards and expectations are met.
• Travel up to 10% of the time both domestically and internationally to support organizational goals.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience.
• 5 years relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics, or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
• Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body.

Preferred Qualifications

• Knowledge of software regulations and compliance (21 CFR Part 11).
• Knowledge of ISO 13485; knowledge of consumer regulations a bonus.
• Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
• Ability to work independently and in groups; ability to work cross-functionally.
• Demonstrated initiative and problem-solving skills and critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize. Strong organizational and project management skills.
• Ability or aptitude to lead without direct authority.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is: $86,700.00 – $173,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

LNGO Lingo

LOCATION:

United States > Alameda : 2901 Harbor Bay Parkway

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day), Keyboard use (greater or equal to 50% of the workday).