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Manager, Quality Assurance
Manager, Quality AssuranceBaxter • Hayward, California, USA
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Manager, Quality Assurance

Manager, Quality Assurance

Baxter • Hayward, California, USA
[job_card.30_days_ago]
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  • [job_card.full_time]
[job_card.job_description]

This is where your work makes a difference.

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 / CAPAs 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 Youll 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 Youll 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.

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 $112000 - $154000 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. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.

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 (except for Puerto Rico)

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 additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site : Benefits Baxter

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.

Know Your Rights : Workplace Discrimination is Illegal

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.

Required Experience :

Manager

Key Skills

Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA / QC,Selenium,HACCP

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 112000 - 154000

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