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Director Infection Control Consumables
Fraser, MI
Job Description
Director Infection Control Consumables
At Getinge and Healthmark 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 and Healthmark, 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.
Job Overview
The purpose of this position is to oversee, drive and support the product segment "IC Consumables" within the Business Area Surgical Workflows in its operation and to liaise with the SW Central QRC Function as well as with the Global QcRM function so that the Global QMS Directives/Procedures and applicable standards and regulations are implemented and followed. In addition, the position will be responsible for the Post Market Integration to ensure the best possible QMS setup within the SW product segment of IC Consumables.
Responsibilities
Job Responsibilities and Essential Duties
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge and Healthmark, 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.
Job Overview
The purpose of this position is to oversee, drive and support the product segment "IC Consumables" within the Business Area Surgical Workflows in its operation and to liaise with the SW Central QRC Function as well as with the Global QcRM function so that the Global QMS Directives/Procedures and applicable standards and regulations are implemented and followed. In addition, the position will be responsible for the Post Market Integration to ensure the best possible QMS setup within the SW product segment of IC Consumables.
Responsibilities
Job Responsibilities and Essential Duties
- Act as a Director for the SW product segment "IC Consumables" and liaise with people at all levels in the organization in a proactive manner.
- Implement the SW QRC strategy in this product segment and provide direction and feedback to individual, team, and organizational developmental efforts necessary to execute the strategy.
- Establish a structure and quality culture which help Getinge to meet all applicable regulations and standards, such as but not limited to FDA QSR, EU MDR 2017/745, ISO 13485 and ISO 9001
- Be a proactive and collaborative member of the SW QRC Management Team
- Provide updates on QRC related issues and achievements and identify new requirements and customer needs to align the SW QRC agenda and strategy.
- Collaborate with business leaders in the Business Area SW and Global QcRM to assess processes, services and solutions and identify process improvements.
- Follow-up metrics and plans and support colleagues related to the strategy, policies, procedures, compliance, complaints, licenses, training and audits.
- Secure a high performing team by recruiting, developing, coaching and leading people
Minimum Requirements
- Minimum Bachelors or Masters Degree in Science, quality or related discipline
- A minimum of 5+ years related Quality and Regulatory Management experience in an FDA regulated environment (medical device experience highly preferred)
- Proven experience in a Quality leadership role and capability and goal oriented management style with capability to manage in a matrix organization with international business partners.
- Experience with risk management, usability, corrective action, complaint
- Adopt the "Quality Culture" in the work environment
Required Knowledge, Skills and Abilities
- Broad knowledge of Quality Management Systems (ISO 13485 and ISO 9001)
- Knowledge in regulations, such as FDA 21CFR820 and EU MDR 2017/245
- Good understanding and experience of Global Regulatory Agencies (competent authorities and notified bodies) requirements and practices
- Knowledge of the product lifecycle (i.e. product development and design change process)
- Good analytical and problem solving skills.
- High level of attention to detail and accuracy.
- Demonstrated ability to interact effectively at all levels of an organization on QRC related issues and practices
- Ability to work and lead in a matrix organization.
- Demonstrated consultative skills
- Intermediate to advanced skills in Microsoft Office package (e.g. Microsoft Word, Excel, PowerPoint) other relevant office IT tools.
About Us
Healthmark Industries headquartered in Fraser, MI is a center of excellence in the SPD consumables area of the Surgical Workflow business area of Getinge, a leading Medtech company. Getinge and Healthmark is on an excitingtransformation journey constantly looking for new ways to innovate together with our customersto meet the healthcare challenges of the future. Our passionatepeople hold our brand promise 'Passion for Life' close to heart.
Ifyoushareourpassionandbelievethatsavinglivesisthegreatestjobinthe world, thenwelook forwardtoreceivingyourapplication and resume. We hope you will join us on our journey to become the world's most respected and trusted MedTec company.
Benefits At Healthmark
At Healthmark, we offer a comprehensive benefits package, which includes:
At Healthmark, we offer a comprehensive benefits package, which includes:
- 401k (Safe Harbor)
- Paid Time Off
- Tuition Reimbursement
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Company paid short term and long term disability
Getinge and Healthmark are 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.
Applicants who require reasonable accommodations to complete a profile or to submit responses to qualifying questions may contact hmhr@hmark.com or 800-521-6224.
Please click below to learn more about your rights as an Applicant under Federal Employment Laws:
- Equal Employment Opportunity is the Law
- EEO is the Law Supplement
- Pay Transparency Policy
- Family and Medical Leave Act (FMLA)
- Employee Polygraph Protection Act
Healthmark Industries Co. participates in the Department of Homeland Security U.S. Citizenship and Immigration Services' E-Verify program (For U.S. applicants and employees only).
Please click below to learn more about the E-Verify program:
- E-Verify Notice (bilingual)
- Right to Work Notice (English) / (Spanish)
Healthmark Industries Co. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Applicants who require reasonable accommodations to complete a profile or to submit responses to qualifying questions may contact hmhr@hmark.com or 800-521-6224.
Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5+ years
Required Security Clearance
Other Clearance
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