Skip to content
CV Rocket
Get started
How it worksThe enginePricingBlogContactSign in

Open nowPosted yesterday

Site Quality Leader

Abbott2,620 open roles

Where
United States - Minnesota - Plymouth
Get the CV for this job

From $25 per CV, paid once. No subscription.

Your applicationOpen nowSite Quality LeaderAbbott · United States - Minnesota - Plymouth

  1. YouYes, apply to this one.

  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Abbott's own form.

The reply lands in your private mailbox

3×more interviews than doing it yourself with ChatGPT.

The clock on this job

Early applications get read.

9.5% of postings close within 7 days. Measured by our own scanner across the market. Abbott postings stay open a median of 28 days.

Share of postings closed within
  1. 1.8%1 day
  2. 3.9%3 days
  3. 9.5%7 days
  4. 15.5%14 days
  5. 33.9%30 days
This job: posted yesterday

Abbott median: 28 days open

The posting

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 122,000 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 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
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists

The Opportunity

The Site Quality Leader is the senior quality authority for the site and a key member of the Site Leadership Team. The role is accountable for ensuring that all products manufactured, tested, and released from the Plymouth, MN and St. Paul, MN Structural Heart facilities meet global regulatory requirements and conform to the Abbott Structural Heart Quality System. In addition, the position is responsible for establishing and leading the quality strategy, driving regulatory compliance, and maintaining the Quality Management System for finished Structural Heart devices and components manufactured at Minnesota facilities.

  • Establish and implement a site quality strategy aligned with business objectives and regulatory expectations
  • Represent Quality on the Site Leadership Team and embed quality principles into site decision making
  • Promote a proactive quality culture focused on risk management, compliance, and continuous improvement
  • Ensure full compliance with global regulatory standards including EU MDR, FDA QMSR, ISO 13845
  • Maintain continuous inspection readiness and lead regulatory inspections
  • Provide quality oversight for Structural Heart manufacturing processes
  • Lead and develop the site quality organization

Location: Plymouth, MN

What You’ll Work On

  • Develop and participate in setting quality assurance strategies and regulations
  • Assess and advise on potential risks, ensures compliance and gives recommendations
  • Take responsibility for all quality control aspects of the process (e.g., testing, operations, raw materials, production, finished products or services)
  • Lead audits and regulatory inspections
  • Establish quality and reliability standards by studying product and consumer requirements with other members of management and production operators, technicians, and engineers
  • Establish standards for the disposition of finished products by devising evaluation tests, methods, and procedures
  • Establish rework standards by devising inspection and physical testing methods and procedures.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
  • Provide directions to managers, exempt specialists and non-exempt support in various areas, groups and/or operations
  • Keep the organization's vision and values at the forefront of decision making and action
  • Build strategic partnerships to further departmental and organizational objectives
  • Interact internally and externally with executive-level management, outside regulatory agencies, customers, vendors and/or suppliers
  • Coordinate across functional areas, business units, and/or geographies to achieve company or area goals
  • Monitor and ensure compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations, etc.).
  • Make and execute operational decisions with a strategic perspective
  • Direct and control the activities and budget of one or more functional areas, divisions, product groups and/or operations
  • Review, analyze and present to senior staff and other groups the effectiveness of the Quality System
  • Recommend and implement changes to the Quality System because of changing regulations and/or business needs
  • Analyze data, make decisions or provide recommendations to senior staff regarding quality-related crises (e.g. patient injury due to product malfunction)
  • Communicate quality policies, strategies and procedures to the organization through written documents, presentations and discussions

Experience You'll Bring

Required Qualifications

  • Bachelor's or advanced degree in Engineering or related field
  • Minimum 12 years of Medical Device manufacturing experience including significant quality leadership roles
  • Comprehensive understanding of FDA, EU MDR, and global regulatory requirements
  • Proven experience leading and developing quality teams in a medical device manufacturing environment
  • Expertise in managing quality systems including CAPA, change control, deviations, complaints, and document control
  • Experience managing regulatory inspections, customer audits, and serving as primary quality interface with authorities
  • Strong written and verbal communication skills
  • Ability to collaborate effectively across all organizational levels

Preferred Qualifications

  • Strong understanding of risk management methodologies and quality tools
  • Proficiency in root cause analysis and implementation of corrective actions
  • Expertise in validation, qualification, and computer system compliance
  • Experience implementing continuous improvement initiatives in a medical device manufacturing setting

The base pay for this position is

$149,300.00 – $298,700.00

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

JOB FAMILY:

Operations Quality

DIVISION:

SH Structural Heart

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

No

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)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

From $25, paid onceGet the CV for this job

What happens when you press

One press. We do the rest.

  1. A CV for this posting

    Written against Abbott's own wording, from every piece of relevant proof in your profile.

  2. 25 readers review it

    Recruiter, hiring manager, skeptic and more read every draft, round after round. You get the best round.

    The review screen in CV Rocket: how each CV was read, round by round.

  3. We apply on Abbott's form

    Our application engine gets through the hardest forms there are. Where a question needs you, AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

    An application in CV Rocket: every answer filled in on the employer's form.

  4. Every reply, sorted

    Abbott's answer lands in your private mailbox, and we classify it on arrival: interview, question, rejection.

    The CV Rocket inbox: each employer reply classified as an interview, an action or a rejection.

  5. Reply with AI

    AI helps you write the email, checks it and sends it. We show you whether the recruiter read it.

  6. The interview in your calendar

    Full integration with your calendar. The invitation goes straight in.

    An interview invitation in the CV Rocket inbox, added to the candidate's calendar.
Get the CV for this job

From $25 per CV, paid once. No subscription.

Why it works

3×

more interviews than doing it yourself with ChatGPT.

ChatGPT writes a CV and never learns what happened to it. We see every reply. For each CV we know:

  • How it was written, and how the review scored it
  • When we applied, and how long after the posting went up
  • Which posting, which company, which city
  • Who got the interview, and who heard nothing

That is how we know which CVs get called.

Get the CV for this job

From $25 per CV, paid once. No subscription.

The numbers game

More applications. More interviews.

Every application goes out with its own CV, written for that posting and paid once. Send enough of them and the law of large numbers finds you the job.

Get the CV for this job
By hand5–10
With CV Rocket100
applications a day

Nearby

Live postings like this one

Same employer first, then the same role elsewhere.

Before you press

Straight answers

Get the CV for this job

From $25 per CV, paid once. No subscription.

What if my background isn't good enough?

We make the most of the background you have. The CV uses every piece of relevant proof your profile holds, and one of the 25 readers reads your whole profile and flags what the CV left out.

Do you really apply for me?

Yes, on the employer's own form, the hardest ones included. Where a question needs you, you answer it right there and AI suggests the best answer. Don't want us applying from our IP addresses? Use our Chrome extension: we apply straight from your own browser.

Is it a subscription?

No. You pay once per CV, from $25. Every application goes out with its own CV, written for that posting.

One job. One CV.
Paid once.

Pick the posting you want. We write for it, apply for you and catch the reply.

Get the CV for this job

From $25 per CV, paid once. No subscription.