Senior Manager, Quality Operations

Job Description

Are you passionate about quality? As a medical device company, it is a part of all that we do. We are looking for a Senior Quality Operations Manager that will formulate and drive manufacturing quality excellence programs designed to assure maintenance of the Company?s competitive position and the profitability of its manufacturing operations. In this position, you will collaborate cross-functionally, assuring goal alignment, with other members of the management team including Business Development, Operations, Engineering, Program Management, Research and Development, Regulatory Affairs, and Quality Systems.? This role provides management oversight of the Quality Operations team at our Smiths Medical site in Oakdale MN, which produces products mainly for the Infusion Systems market and will serve as the Management Representative per ISO 13485 and FDA 21CFR820.

Duties and Responsibilities

  • Lead manufacturing and supplier quality initiatives to ensure Smiths product quality standards are consistently achieved and maintained.

  • Ensure that processes are sufficiently capable to deliver and maintain Smiths quality standards, and develop action plans using cross functional teams to address weaknesses or deficiencies.

  • Develop and implement policies and processes to ensure Smiths quality standards are detailed, robust, communicated and measured consistently throughout internal manufacturing and external suppliers

  • Critically analyze, using appropriate sources of data, Smiths Medical operations capabilities; setting strategy, structure, and processes to drive sustained quality improvement in local manufacturing facility.

  • Develop world class, common systems for completely integrating Quality Management Systems with Operational processes and the Smiths Operating System. Develop key metrics and scorecards to measure quality level performance within the manufacturing facility

  • Align site and quality objectives with the Business Plan, Operations Objectives, and the Global Manufacturing Quality System to assure effective and efficient use of resources and manufacturing quality excellence

  • Set facility level Quality operations goals and objectives for customer focused quality initiatives. In particular analyze customer complaint trend data and set strategies, structure and processes to drive improvements in operations quality.

  • Collaborate with NPI teams to ensure that quality attributes, manufacturability and lessons learned from existing products (e.g. production performance, quality problems, complaints) are integrated into the design and manufacturing processes.

  • Assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site).

  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.

Required Skills and Experience

Technical Knowledge and Skills:

  • Bachelor?s degree in Science or Engineering from an accredited college or university, and at least 10 years of experience in Medical Device Quality Operations, with 5 or more years at a senior level, or equivalent.

  • Master?s degree in Science or Engineering preferred

  • Experience productively interfacing with marketing, business development, engineering, manufacturing, quality, and regulatory functions

  • Broad extensive knowledge of methods, processes, equipment, and techniques in manufacturing, development and engineering

  • Expertise with the domestic and international medical device regulatory environment including the EU Medical Device regulation, FDA 21CFR820, FDA 510(k)/PMA process and approvals, FDA and Notified Body audits and review, design control documentation and internal guidelines

  • Intermediate to advanced skill level with MS Office suite of programs

  • In-depth knowledge of ISO 13485:2016; Lead Auditor certification preferred

  • Knowledge of state of the art manufacturing processes, preferably in the medical device industry

  • Effective leadership skills and ability to influence department and peers, as well as be a team player

  • Excellent verbal & written communication skills (internal & external customers)

  • Knowledge of finance and accounting business functions


  • Proven ability to formulate Quality Operations facility strategies. Ability to plan, direct, and maintain long term roadmap and short term goals.

  • Proven ability to successfully develop global systems and processes to deliver quality standards and targets

  • Demonstrated ability to coach, mentor and develop technical and scientific talent within the company

  • Proven ability to function in a high-growth environment

  • The ability to convey a compelling view and be an independent and creative thinker

  • Good business acumen and understanding that Operations and Quality are a critical part of a business enterprise

  • Must possess high degree of organization, coordination and influencing skills and be a self-starter

  • Strong decision making ability is desired

  • Positive attitude - morale booster

  • Ability to plan and prioritize activities as well as ability to work independently to meet assigned project deadlines

  • Ability to appropriately handle confidential information

About Us

At Smiths Medical, we are passionate about improving and saving the lives of patients through high quality, innovative medical devices and services. We are a leading global manufacturer of specialty medical devices that provides innovative and lifesaving solutions for the world?s healthcare markets.

Specializing in Infusion Therapy, Vascular Access, Vital Care, and Specialty Products & Services, our products are found in hospital, emergency, home and specialty care environments and are used during critical and intensive care, surgery, post-operative care and for supporting managing chronic illness.

Smiths Medical is an EEO/AA Employer/Vet/Disabled

If you require assistance with our online job submission process, please contact our Talent Acquisition team at 855-754-5032 ?to request an accommodation. Additionally, Smiths Medical invites interested deaf and hard of hearing applicants to use Video Relay Service (VRS).

Don't Be Fooled

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will bounce and the victim is left responsible.

More Jobs

Senior Manager Quality Engineering
Minneapolis, MN Abbott
Senior Manager Quality Engineering
Minneapolis, MN Abbott Laboratories
Senior Manager Quality Program
Dodge Center, MN Oshkosh Corporation
Senior Supplier Quality Engineer
Minneapolis, MN Integer
Manager Cash Operations
Minneapolis, MN North Memorial