Process Compliance Engineer

Job Description:

SUMMARY:

The Process Compliance Engineer shall be responsible for process compliance and shall act as a specialist within his/her field. The role shall provide solid knowledge in manufacturing within GMP, ISO 13485 (Medical device) and validation. He/she shall take ownership for the strategic work within these fields as part of the engineering department.

• Overlook already established processes for risk mitigation and process success purpose. The process could be in the manufacturing but also our internal processes set up for validation, periodic review, GMP training, pFMEA etc.
• The role shall provide guidance and knowledge when establishing new processes when it comes to GMP and validation strategy.
• The role shall act as an specialist and guide the team and company to success when it comes to GMP and manufacturing excellence within the field. He/she shall provide best practice guidance and take Lead/participate in Non-conformance investigation.
• The role shall act as an SME within the field and support both engineering, production and quality to ensure compliance.
   

Job Requirements:

REQUIREMENTS:

• Bachelors in Engineering or related field; Master's is a plus
• 5+ years experience in FDA medical device regulation (ISO 13485); process or validation engineering experience
• Audit experience preferred
• ISO class 7; clean room experience
• Experience working in Cross Functional teams 
• Strong GMP knowledge; process validation and qualification in a GMP industry
• pFMEA experience in a GMP industry
• Use of statistic tools for analysis and process set up.
• Analyze data and identify trends for monitoring and implement corrective actions.
• Excellent communication skills; both written and verbal
• Excellent organizational skills 

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

Operating Company:

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.