Supervisor, Quality Assurance (Onsite) - Englewood, CO

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows.

Every day we collaborate to make a true difference for our customers and to save more lives.

Are you looking for an inspiring career? You just found it.

At Getinge, we exist to make life-saving technology accessible for more people. To meet future expectations and perform at our best, we need Team players, Forward thinkers and Game changers.

Located in the beautiful Inverness Business Park, Getinge offers a generous benefit package (including access to health insurance, time off accruals and 401k participation - day of hire), a robust PTO program and fully supports the "work / life balance" philosophy.

As an FDA and ISO-regulated business, an NDA is required. This is a 5-day / week, on-site position.

Job Function Summary :

The Quality Supervisor is responsible for managing the daily functions of the Quality operations pertaining to the production of manufactured product, including Medical Devices.

Responsible for oversight of the Quality Laboratory and review and completion of all in-process quality checks pertaining to a Device Master Record.

Responsible for determining effectiveness of quality systems and analysis of departmental needs. Responsible for direct supervision of receiving inspector and quality laboratory.

The Quality Supervisor will have direct reports including QC Laboratory Technicians and Quality Control Floor Technicians.

Job Functions :

• Make essential quality decisions regarding received in, in-process, or final release items in accordance to FDA 21CFR820 regulations and ISO 14385 regulations.
• Manage flow of quality work and determine priorities
• Train or cross train employees on quality related jobs
• Write Part Specifications for new components / products
• Reviewing and signing as final responsible party for Change Orders related to Products, raw materials or quality procedures.
• Operation and use of calipers, micrometers and other measurement equipment and tools.
• Operation of any other equipment necessary to assure that components and products meet specifications.
• Performance of receiving methods for all in-coming items.
• Performance of inspection methods for all in-coming components.
• Performance of inspection methods for all screen printing, lamination, cutting, and packaging components and assemblies.
• Performance of First Article inspection methods.
• Inspection acceptance criteria decisions for all in-coming and in-process components and assemblies.
• Non-Conforming Item Report processing.
• In process floor inspections including verification of Device History Record and Pick List documentation.
• Verification of Corrective Actions resulting from Non-Conformities.
• Manage Change Control Activities related to production.
• Other QC duties as designated by the Operations Manager or Local Quality Manager
• Support Internal and External Audit Activities.
• Manage Quality Records related to production and quality activities, i.e : Device History Records and Nonconformance records.
• Monitor team schedules and authorize Overtime as necessary.
• Coach team on performance training and development.
• Responsible for timely completion of 90-Day and Annual Appraisals.
• Counsel and administer Performance Communications (corrective actions) as necessary, with the assistance of Human Resources

Required Knowledge, Skills and Abilities :

• In-depth knowledge of ISO 13485 : 2016 and FDA 21CFR820 requirements. Knowledge of EU MDR beneficial
• Analytical mindset with strong problem solving skills
• High level of attention to detail and accuracy
• Strong computer skills, including MS Office applications (Word / Excel) and Microsoft Project are required
• Proficiency in relevant software applications (e.g., document management systems, quality management systems) is a plus
• Demonstrated leadership experience with the ability to lead and develop a team, drive accountability, and foster a culture of quality and compliance
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, regulatory agencies, and external stakeholders

Minimum Requirements :

• Bachelor’s Degree or equivalent work experience (Associates degree plus 3 years experince or High School Diploma plus 5 years of experience)
• A minimum of five years Medical Device Product Quality experience preferred or any regulated industry experience.
• Experience in with FDA 21CFR820 and ISO13485 : 2016.

Quality Requirements :

• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).
• Attend all required Quality & Compliance training at the specified interval.
• Adopt the Beyond Compliance Quality Culture in the work environment; always meet and exceed requirements.

Environmental / Safety / Physical Work Conditions :

• Daily use of computer / laptop and related accessories in an office environment
• Occasional work in controlled environment
• Ensures environmental consciousness and safe practices are exhibited in decisions.
• Use of computer and telephone equipment and other related office accessories / devices to complete assignments.
• May work extended hours during peak business cycles.
• Hearing necessary to receive and reply to outside contacts and employees.
• Ability to speak clearly in order to communicate with outside contacts and employees in person and on the telephone.
• Must be willing to work in a sitting position for long periods of time.
• Some bending, stooping, reaching and lifting (up to 30 pounds) is required.
• Willingness to frequently move to various locations within and outside of the building.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Supervision / Management Of Others : Responsible for the development and management of personnel and programs in the QC Lab department as well as the Floor Inspection Techs.

Pay Range : $28 - $35 / hour DOE

Disclaimer : The above information in this description is intended to describe the general nature and level of work performed.

It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.

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About us

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future.

Our passionate people hold our brand promise Passion for Life’ close to heart.

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume.

We hope you will join us on our journey to become the world’s most respected and trusted MedTec company.

Benefits at Getinge :

At Getinge, we offer a comprehensive benefits package, which includes :

• Health, Dental, and Vision insurance benefits
• 401k plan with company match
• Paid Time Off
• Wellness initiative & Health Assistance Resources
• Life Insurance
• Short and Long Term Disability Benefits
• Health and Dependent Care Flexible Spending Accounts
• Commuter Benefits
• Parental and Caregiver Leave
• Tuition Reimbursement

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.