Project Management Process Specialist

As a Project Management Process Specialist at KARL STORZ , you will be involved in all new and change product development projects and provide fundamental support.

The successful candidate must be able to balance multiple projects at one time while maintaining the same level of quality across each program.

The Project Management Process Specialist works with Project and Program Managers to create, release, and store documentation related to Design History Files (DHF), Technical Documentation, and other Regulatory and project requirements.

You will monitor submitted documentation to ensure that it complies with current process standards and provide local support and guidance for Global Product Development Processes (GPDP).

The Project Manager Process Specialist will also support project related internal and external audits.

ESSENTIAL FUNCTIONS : List the essential duties and responsibilities of the position, in order of importance and / or amount of time spent.

• Assist in the creation, release, storage, and maintenance of project documentation related to Design History Files, Technical Documentation, and other Regulatory and project requirements.
• Work with Project Managers and Engineers to process documentation in the Engineering Change Management System, especially during new product development and product improvements.
• Responsible for meeting with Project Managers regarding fulfillment of their Engineering Design Control requirements for their projects.
• Schedule stakeholder meetings, as required, and attend meetings to document important actions and decisions.
• Prepare necessary presentation materials for meetings.
• Researches and gathers data, as needed, to conduct preliminary analysis. Recommends content and format to display findings most effectively.
• Support internal and external audits.
• Monitor GPDP documentation to ensure that project documentation complies with current standards.
• Foster teamwork while contributing to cross-functional project teams.
• Participate and / or assist in writing and updating procedures, protocols and checklists.
• Regular attendance is an essential job function.
• Travel : up to 10% travel during the year.

ADDITIONAL RESPONSIBILITES :

The Project Management Process Specialist will spend part of their time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of Karl Storz's products and services.

Responsible for creating and maintaining work instructions for job specific duties.

Performs other related duties as assigned by supervisor

KNOWLEDGE, SKILLS, ABILITIES :

• Demonstrated experience understanding and following documented protocols and procedures.
• Exceptional verbal, written and presentation skills
• Proficiency in Microsoft Office 365
• Ability to work on multiple projects and priorities simultaneously
• High level of interpersonal skills to handle sensitive and confidential information and documents
• Drive and passion to learn new applications in project support and process management
• A proven track-record of problem resolution and the ability to make sound decisions in a fast-paced environment
• Excellent teamwork capabilities
• Experience in documentation archival systems and / or SAP
• Strong capabilities within MS Word for formatting and developing forms and templates
• Strong capabilities within MS Excel in creating formulas and pivot tables
• Must be proficient in simple data analysis techniques, primarily using MS Excel

EDUCATION AND EXPERIENCE :

• Bachelor's degree or 5+ years of experience in related field
• Minimum 5 years' experience working in a regulated environment such as medical devices and experience with Quality Management Systems and Medical Device Regulations : 21 CFR 820, ISO 13485, ISO9001.

PHYSICAL & MENTAL REQUIREMENTS :

• Must have adequate eyesight (can be corrected) in order to work with paper documents and interface with computer.
• Ability to lift and carry 20 pounds
• Stand for moderate amounts of time (2-3 hours per day).
• Sit and input data for long periods of time (6-7 hours per day).
• Work effectively under pressure and time constraints.
• Communicate clearly with supervisor and co-workers.

TRAINING REQUIREMENTS :

• Injury and Illness Prevention Program; annually - OSHA requirement
• Quality System training
• Job Specific - In house requirement

LEVEL OF SUPERVISION REQUIRED :

• Minimal supervision required
• Individual responsible for organizing and prioritizing their time to support multiple projects
• Responsibilities are assigned based on general goals developed by the supervisor.

INTERFACE.

• Project Managers- to create, release, store, and maintain project documentation related to Design History Files, Technical Documentation, and other Regulatory and project requirements.
• Product Development Project Team Members, Manufacturing, QSSC, Compliance- same as above
• Internal and External Auditors - front and / or backroom coordinator or interface for Product Development documentation related questions.
• Document Control and EC Change Board members- Coordination of product release to EC system.
• It is each employee's obligation to consistently treat visitors, external customers and all co-workers with courtesy and respect

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Eligible Employee Benefits

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!
• 3 weeks vacation, 11 holidays plus paid sick time
• Up to 8 weeks of 100% paid company parental leave; includes maternal / paternal leave, adoption, and fostering of a child.
• 401(k) retirement savings plan providing a match of 60% of the employee's first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employees must comply will all applicable KARL STORZ policies and procedures.

Credentialing requirements at KARL STORZ

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing / health screens as a condition of employment.

Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing / health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

Pay Transparency

The pay range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected].

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