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Manager, Quality Assurance

Manager, Quality Assurance

BaxterHayward, CA, US
8 hours ago
Job type
  • Full-time
Job description

Job Opportunity At Baxter

At Baxter, we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a jobyou will find purpose and pride.

Job Description

Your Role At Baxter :

Incumbent is responsible for day-to-day activities of Quality Operations, Quality Assurance, Inspections / Release, Compliant Investigations and NCRs / CAPA's, cGMP compliance and Inspection readiness by ensuring quality and compliance are built into day-to-day operations.

Your Team :

Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each shift. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce.

What You'll Be Doing

  • Implementation and improvement of Quality Processes that will ensure compliance with regulations, corporate and local procedures, and specifications.
  • Quality Representative in the manufacturing areas.
  • Manage the batch review and release activities.
  • Interfaces with regulators during regulatory inspections / audits.
  • Identifies and manages continuous improvement and VIP projects with the objective of achieving quality, reliability, and cost improvements.
  • Ensure adherence to budget.
  • Support change control activities for manufacturing operations.
  • Manage the release process, inspection, and batch release activities.
  • Oversee, initiate, investigate and approve non-conformance report activities as needed.
  • Promote a zero-harm workplace and ensure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
  • Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability, and cost improvements.
  • Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
  • Interacts frequently with all levels of internal management as well as across functions and franchises.
  • Manages overall coaching, training, development, and succession plans for the team.

What You'll Bring

  • BS in science or engineering. 5+ years' experience in Quality, Manufacturing, Engineering, or related field which should include 1-2 years of supervisory experience in a Medical Device or Pharma Industry.
  • Thorough knowledge of applicable procedures, specifications, regulations, and standards.
  • Strong leadership skills and demonstrated success in managing mid-to-large teams. Capable of managing in matrix and ability to interact successfully with multi-functions globally.
  • Strong analytical and problem-solving skills.
  • Ability to manage / supervise a team of employees.
  • Good communication and leadership skills.
  • Good interpersonal / communication / influencing / negotiation skills.
  • Comfortable and capable of gowning into an ISO 7 / ISO 8 manufacturing environment.
  • Compensation

    We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

    Work Authorization

    Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

    US Benefits At Baxter

    This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.

    Equal Employment Opportunity

    Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.

    Reasonable Accommodations

    Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

    Recruitment Fraud Notice

    Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and / or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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