Senior Quality Systems Specialist

Redbock - an NES Fircroft company; Minnesota; Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company in biotechnology is seeking a Business Process Analyst to join their global PLM implementation team. The role involves translating and documenting business processes for the Windchill system, ensuring a smooth transition for end-users. Candidates should have a strong background in process documentation and mapping, along with excellent communication skills. This is a 24-month contract position with minimal travel required.

Benefits

Vision insurance

Medical insurance

401(k)

Disability insurance

Qualifications

• 3-5 years of experience in a Business Process Analyst role.
• Proven experience with PLM systems, ideally Windchill.
• Strong written and verbal communication skills.

Responsibilities

• Translate current and future state business processes for PLM.
• Collaborate with SMEs and stakeholders across various functions.
• Document process flows and maintain organized documentation.

Skills

Process documentation

Process mapping methodologies

Interviewing skills

Requirements gathering

Strong communication skills

Attention to detail

Organizational skills

Education

Bachelor's degree in Business Administration, Information Systems, Engineering, or related field

Tools

Visio

Lucidchart

BPMN

Job description

Direct message the job poster from Redbock - an NES Fircroft company

Recruitment Consultant II at Redbock - an NES Fircroft company

Sr. Quality Systems Specialist (24 month contract // REMOTE):

Ability to travel: Minimal, up to 10% for site implementation visits

Top Required Skills:

• 3-5 years of experience in a role involving process documentation and mapping, including demonstrated proficiency in process mapping methodologies and tools (e.g., Visio, Lucidchart, BPMN)
• Proven experience working with Product Lifecycle Management (PLM) systems (ideally Windchill)
• Excellent interviewing and requirements gathering skills, with the ability to translate technical concepts into clear business process documentation

Description:

Product DNA is a transformational program across our client’s enterprise to simplify the way their team creates, manages, and utilizes product data. The north star vision of Product DNA is to create a foundational connected digital thread of product information. The Product DNA program will improve upon outdated technology and infrastructure through streamlining systems used across the organization, as well as implementing best-in-class practices and procedures. This change will impact all groups, functions, and regions across the organization and will be a multi–year, multi-phase program.

Client is seeking a detail-oriented and collaborative Business Process Analyst (BPA) to join our global Windchill PLM implementation program team. In this critical role, you will be responsible for translating the current state ("as-is") business processes performed within our existing Product Lifecycle Management (PLM) system across various global design and manufacturing sites. You will then work closely with subject matter experts and the project team to document how these processes will be mapped and executed ("to-be") within the new Windchill PLM environment. Your work will be essential in creating clear documentation that bridges the gap between current operations and future state functionality, ensuring a smooth transition for end-users.

Duties:

• Collaborate with end-users, subject matter experts (SMEs), and project stakeholders across different functional areas (Engineering, Manufacturing, Quality, Regulatory) and site locations.
• Support interviews, workshops, and reviews of existing documentation to thoroughly understand and translate current PLM-related business processes ("as-is") for approval by customers and downstream consumption by the core design team and stakeholders.
• Identify opportunities for consolidation of duplicative/overlapping documents and common processes, and support QMS Standardization efforts where needed.
• Create clear, concise, and accurate process flow diagrams (using tools like Visio, Lucidchart, etc.) and narratives of current state operations.
• Work with the implementation team and SMEs to understand the defined future state processes within Windchill.
• Document the future state ("to-be") process flows, clearly illustrating how tasks currently performed in the legacy system will be accomplished in Windchill.
• Map the relationships and transformations between "as-is" and "to-be" processes, highlighting key changes for users.
• Support the development of training materials and communication plans by providing clear process documentation.
• Maintain organized documentation repositories for easy access and review.

Required Skills:

• Bachelor's degree in Business Administration, Information Systems, Engineering, or a related field.
• 3-5 years of experience in a Business Process Analyst, Process Analyst, or similar role involving process documentation and mapping.
• Proven experience working with Product Lifecycle Management (PLM) systems.
• Demonstrated proficiency in process mapping methodologies and tools (e.g., Visio, Lucidchart, BPMN).
• Excellent interviewing and requirements gathering skills.
• Strong written and verbal communication skills, with the ability to translate technical concepts into clear business process documentation.
• High attention to detail and commitment to accuracy.
• Ability to work effectively both independently and as part of a cross-functional team.
• Strong organizational and time management skills.

Preferred Skills:

• Direct hands-on experience with PTC Windchill PLM.
• Experience working within a regulated industry (Medical Device, Pharmaceutical, Aerospace, Automotive) and familiarity with associated quality systems (e.g., QMS, ISO 13485, GxP).
• Experience participating in large-scale system implementation projects (ERP, PLM, MES).
• Familiarity with core PLM concepts such as Document Management, Change Management, Bill of Materials (BOM) Management.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Consulting and Quality Assurance

• Industries

  Biotechnology Research and Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Redbock - an NES Fircroft company by 2x

Inferred from the description for this job

Vision insurance

Medical insurance

401(k)

Disability insurance

Get notified when a new job is posted.

Sign in to set job alerts for “Quality System Specialist” roles.

Quality Management Engineer - Design Controls - National Remote

Supervisor of Quality Operations CEQ National Data Mining Team - Remote

Senior Software Quality Assurance Engineer (QA)

HEDIS User Acceptance Testing SME - Clinical and Quality Solutions - Remote

HEDIS User Acceptance Testing SME - Clinical and Quality Solutions - Remote

HEDIS User Acceptance Testing SME - Clinical and Quality Solutions - Remote

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.