Quality Manager HPM Consumables Business

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Company: Spectranetics

Location: Lockbourne, OH 43137

Description:

Job Title
Quality Manager HPM Consumables Business

Job Description

Are you passionate about ensuring the highest quality standards in healthcare? We are looking for a dedicated Quality Manager for the Hospital Patient Monitoring Consumables Business to join our dynamic team. In this role, you will work closely with colleagues and key stakeholders to drive and uphold the highest standards of quality, ensuring that our products are not only reliable but also state-of-the-art.

With a focus on excellence, you will play a pivotal role in delivering innovative and life-changing solutions to 2.5 billion patients around the world, improving their health and well-being.

Your role:
  • As part of the Quality Operations Organization at Philips, your challenge will be to guide and support business partners and enabling functions with important decisions about patient safety and product quality. This involves being a confident advisor on approval for product quality, regulatory compliance and quality management related topics, in order to achieve timely shipment and releases of innovative products and processes that deliver high quality and outstanding reliability to the lives they will improve.
  • You will lead a team of around five motivated professionals and will work with business partners from industrialization, supplier engineering and factory and warehouse management to achieve business goals while adhering to the highest standards in quality.
  • Teaming up with counterparts from other Philips' locations and stakeholders to exchange best practices and participate in onsite collaborative projects.


You're the right fit if:
  • You've acquired 5+ years of engineering experience (preferably in the quality space) with process validation, NC handling, hold, environmental control, calibration, preventive maintenance, audit preparation, and QMS procedures.
  • You have a master's degree in a technical discipline and 5+ years of experience with medical devices or in another regulated industry.
  • Your skills include the ability to positively influence your team and stakeholders to make the right decisions about patient safety and quality by acting as a cross-functional partner. Knowledge of regulations such as ISO13485, 21CFR Part 820, ISO14971 paired with pragmatism in application and execution is essential.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
  • You're experienced with internal and external audits, follow-ups, and handling of non-conforming products combined with disposition activities and Corrective and Preventive Actions (CAPA). A lean, hands-on management style is crucial for success in this space. Experience working in an international environment is preferred.


How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.

This is an onsite role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
  • Learn more about our business.
  • Discover our rich and exciting history.
  • Learn more about our purpose.
  • Learn more about our commitment to our culture.


Philips Transparency Details

The pay range for this position in Ohio is $84,000 to $134,400

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Lockbourne, OH. USA

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

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